Marion Laboratories, Inc.
Mchenry, IL, US
Marion Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 38 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 38
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 38 510(k) clearances for Marion Laboratories, Inc. between 1978 and 1989. The busiest year on record is 1978, with 8. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 8 |
| 1979 | 3 |
| 1980 | 3 |
| 1981 | 4 |
| 1982 | 1 |
| 1983 | 4 |
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 5 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K883391 | POLYMER ADHESIVE BANDAGE | NAD | Substantially Equivalent for Some Indications | |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | DKE | Substantially Equivalent | |
| K875181 | MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM | Substantially Equivalent | ||
| K874554 | ENVICLUSIVE (TM) | NAD | Substantially Equivalent | |
| K874552 | ENVISAN PAD | KOZ | Substantially Equivalent for Some Indications | |
| K874551 | ENVINET(TM) | EFQ | Substantially Equivalent for Some Indications | |
| K874553 | ENVISAN PASTE | KOZ | Substantially Equivalent for Some Indications | |
| K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST | LLH | Substantially Equivalent | |
| K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST | LLH | Substantially Equivalent | |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | KZJ | Substantially Equivalent | |
| K853073 | CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. | GTZ | Substantially Equivalent | |
| K852044 | CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI | LLH | Substantially Equivalent | |
| K851399 | BAC-T-SCREEN | JXA | Substantially Equivalent | |
| K845008 | BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE | KZJ | Substantially Equivalent | |
| K833917 | BAC-T-SCREEN | JTA | Substantially Equivalent | |
| K831456 | TOXI-LAB CANNABINOID THC SCREEN | DKE | Substantially Equivalent | |
| K830372 | ARTIMICROBIAL REMOVAL DEVICE | LJF | Substantially Equivalent | |
| K823850 | BAC-T-SCREEN BACTERIURIA DETECTION DEV | JXA | Substantially Equivalent | |
| K823523 | TOXI-LAB RAPID SCREEN | DKJ | Substantially Equivalent | |
| K822344 | ANTIMICROBIAL REMOVAL DEVICE (ARD) | LJF | Substantially Equivalent | |
| K812919 | MULTI-GRAM DEVELOPING TANK R-12 & R-3 | DKK | Substantially Equivalent | |
| K811067 | BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M | KZT | Substantially Equivalent | |
| K810613 | ANTIMICROBIAL REMOVAL DEVICE | MDB | Substantially Equivalent | |
| K803298 | MINI-TIP CULTURETTE | JTW | Substantially Equivalent | |
| K802319 | HEMOTEMP TM | KSE | Substantially Equivalent | |
| K800052 | ANTIMICROBIAL REMOVAL DEVICE (ARD) | Substantially Equivalent | ||
| K792654 | CULTURETTE BRAND-PVA/FORMALIN KIT | IFQ | Substantially Equivalent | |
| K791724 | BIO-BAG ENVIRONMENTAL CHAMBER (A & B) | JTX | Substantially Equivalent | |
| K790815 | CULTURETTE BRAND PVA | IGM | Substantially Equivalent | |
| K790265 | LEVO-STAND-UP WHEELCHAIR | IPL | Substantially Equivalent | |
| K782016 | SPIROCARE 108-B | BWF | Substantially Equivalent | |
| K781869 | DROPPER, CEPTI-SEAL KOH SOLUTION | KEQ | Substantially Equivalent | |
| K781868 | DROPPER, CEPTI-SEAL LAVTOPHENOL | KEQ | Substantially Equivalent | |
| K781062 | DROPPER, SOLUTION TRICHROME, CEPTI-SEAL | HYW | Substantially Equivalent | |
| K781061 | DROPPERS, SOLUTION, IODINE | JTS | Substantially Equivalent | |
| K780440 | CHAMBER, AEROBIC | JTW | Substantially Equivalent | |
| K780222 | I.V. START KIT | FRO | Substantially Equivalent | |
| K780346 | MIF PROCEDURE KIT | JTS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GTZAntisera, All Groups, Streptococcus Spp.
- KOZBeads, Hydrophilic, For Wound Exudate Absorption
- DKJColorimetry, Salicylate
- LJFDevice, Antimicrobial Drug Removal
- KZJDevice, Gas Generating
- FRODressing, Wound, Drug
- NADDressing, Wound, Occlusive
- IFQFormulations, Mercuric Chloride For Tissue
- EFQGauze/Sponge, Internal
- KZTKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin
- JXAKit, Screening, Urine
- KEQMedia, Mounting, Water Soluble
- JTAMonitor, Microbial Growth
- LLHReagents, Clostridium Difficile Toxin
- DKEReagents, Test, Tetrahydrocannabinol
- KSERefrigerator, Freezer, Blood Storage
- IGMSolution, Carnoy'S
- BWFSpirometer, Therapeutic (Incentive)
- HYWStain, Trichrome, Mallory'S
- JTSStains, Microbiologic
- MDBSystem, Blood Culturing
- JTWSystem, Transport, Aerobic
- DKKTanks, Developing, Tlc
- JTXTransport Systems, Anaerobic
- IPLWheelchair, Standup
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain