Neogen Culture Media
Lansing, MI, US
Neogen Culture Media appears in FDA device records in Lansing, MI. FDA records list 177 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Neogen Culture Media carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Acumedia Manufacturers, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 177FDA records hold 177 510(k) clearances for Neogen Culture Media between 1981 and 1988. The busiest year on record is 1981, with 77. The most recent is 1988, with 59.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 77 |
| 1983 | 36 |
| 1984 | 5 |
| 1988 | 59 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K881579 | AMIES TRANSPORT MEDIUM W/O CHARCOAL | JSN | Substantially Equivalent | |
| K881578 | STREPTOSEL | JSJ | Substantially Equivalent | |
| K881577 | MODIFIED SELECTIVE STREPTOCOCCUS AGAR | JSI | Substantially Equivalent | |
| K881576 | SELENITE BROTH | JSI | Substantially Equivalent | |
| K881575 | SELECTIVE STREPTOCOCCUS AGAR | JSI | Substantially Equivalent | |
| K881574 | W-L DIFFERENTIAL MEDIUM | JSJ | Substantially Equivalent | |
| K881573 | PHYTONE YEAST EXTRACT AGAR | JSJ | Substantially Equivalent | |
| K881572 | XL AGAR BASE | JSI | Substantially Equivalent | |
| K881571 | YM BROTH | JSJ | Substantially Equivalent | |
| K881570 | SABOURAUD MALTOSE AGAR | JSJ | Substantially Equivalent | |
| K881569 | STUARTS TRANSPORT MEDIUM | JSM | Substantially Equivalent | |
| K881568 | WILKENS CHALGREN BROTH | JSO | Substantially Equivalent | |
| K881567 | WILKENS CHALGREN AGAR | JSO | Substantially Equivalent | |
| K881566 | HEMOGLOBIN POWDER | JSK | Substantially Equivalent | |
| K881565 | INHIBITORY MOLD AGAR | JSJ | Substantially Equivalent | |
| K881564 | TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT | JSG | Substantially Equivalent | |
| K881563 | TRYPTOSE PHOSPHATE BROTH | JSG | Substantially Equivalent | |
| K881562 | TRYPTOSE BLOOD AGAR BASE | JSG | Substantially Equivalent | |
| K881561 | TERGITOL 7 BROTH | JSJ | Substantially Equivalent | |
| K881560 | UREA BROTH | JSH | Substantially Equivalent | |
| K881559 | UREA AGAR BASE | JSH | Substantially Equivalent | |
| K881558 | TRYPTOSE AGAR | JSG | Substantially Equivalent | |
| K881557 | TRYPTONE | JSG | Substantially Equivalent | |
| K881556 | TRICHOMONAS BROTH | JSI | Substantially Equivalent | |
| K881555 | TINSDALE AGAR BASE | JSI | Substantially Equivalent | |
| K881554 | SKIM MILK DEHYDRATED | JSG | Substantially Equivalent | |
| K881553 | RUSSELL DOUBLE SUGAR AGAR | JSH | Substantially Equivalent | |
| K881552 | PROTEOSE NO. 3 AGAR | JTY | Substantially Equivalent | |
| K881551 | PHENOL RED BROTH BASE | JSH | Substantially Equivalent | |
| K881550 | OF BASAL MEDIUM | JSG | Substantially Equivalent | |
| K881549 | MYCOLOGICAL AGAR W/LOW PH | JSJ | Substantially Equivalent | |
| K881548 | MPH AGAR | JSG | Substantially Equivalent | |
| K881547 | MITIS SALIVARIUS AGAR | JSJ | Substantially Equivalent | |
| K881546 | MALT EXTRACT AGAR | JSG | Substantially Equivalent | |
| K881545 | MALT EXTRACT | JSG | Substantially Equivalent | |
| K881544 | LITTMAN AGAR | JSJ | Substantially Equivalent | |
| K881543 | LETHEEN AGAR | JSG | Substantially Equivalent | |
| K881542 | HEART INFUSION AGAR | JSG | Substantially Equivalent | |
| K881541 | GELATIN | JSG | Substantially Equivalent | |
| K881540 | FLO AGAR | JSH | Substantially Equivalent | |
| K881539 | AMIES TRANSPORT MEDIUM | JSM | Substantially Equivalent | |
| K881538 | ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR | JSA | Substantially Equivalent | |
| K881537 | ANTIBIOTIC MEDIUM #19 | JSA | Substantially Equivalent | |
| K881536 | ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR | JSA | Substantially Equivalent | |
| K881535 | ANTIBIOTIC MEDIUM #6 | JSA | Substantially Equivalent | |
| K881534 | ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR | JSA | Substantially Equivalent | |
| K881533 | BLOOD AGAR BASE NO. 2 | JSG | Substantially Equivalent | |
| K881532 | BLOOD AGAR BASE W/LOW PH | JSG | Substantially Equivalent | |
| K881531 | BLOOD AGAR BASE, IMPROVED | JSG | Substantially Equivalent | |
| K881530 | BRILLIANT GREEN AGAR W/SULFADIAZINE | JSJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1120041 | 1120041 | Neogen Culture Media | 740 EAST SHIAWASSEE, LANSING, MI 48912 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JSQChromatography For Bacterial Identification
- JSACulture Media, Antibiotic Assay
- LKACulture Media, Antimicrobial Susceptibility Test
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- JTYCulture Media, For Isolation Of Pathogenic Neisseria
- JSCCulture Media, General Nutrient Broth
- JSECulture Media, Multiple Biochemical Test
- JSMCulture Media, Non-Propagating Transport
- JSHCulture Media, Non-Selective And Differential
- JSGCulture Media, Non-Selective And Non-Differential
- JSNCulture Media, Propagating Transport
- JSICulture Media, Selective And Differential
- JSJCulture Media, Selective And Non-Differential
- JSDCulture Media, Selective Broth
- JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- JSKSupplement, Culture Media
- JAKSystem, X-Ray, Tomography, Computed
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0283-2019 | Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans. | Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021. | Class III | Terminated | |
| Z-0284-2019 | Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans. | The product is labeled with an incorrect expiration date. | Class III | Terminated | |
| Z-2221-2017 | Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production | Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C. | Class III | Terminated | |
| Z-2212-2017 | Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds | Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C. | Class III | Terminated | |
| Z-1093-2017 | Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes | light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts. | Class II | Terminated | |
| Z-2213-2017 | Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic. | Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018. | Class III | Terminated | |
| Z-2584-2017 | Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples. | Contamination of product with possible Bacillus spp | Class II | Terminated | |
| Z-2214-2017 | Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application. | Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain