Isle Media and Sterile Products, Inc.
Mchenry, IL, US
Isle Media and Sterile Products, Inc. appears in FDA device records in Mchenry, IL. FDA records list 93 510(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
- 93
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 93FDA records hold 93 510(k) clearances for Isle Media and Sterile Products, Inc. between 1979 and 1983. The busiest year on record is 1979, with 78. The most recent is 1983, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 78 |
| 1980 | 8 |
| 1981 | 4 |
| 1982 | 2 |
| 1983 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K831671 | MODIFIED SOYBEAN CASEIN DIGEST BROTH | JSG | Substantially Equivalent | |
| K821218 | CAMPY-S AGAR | JSJ | Substantially Equivalent | |
| K820863 | MEDIA FOR IN-VITRO DIAGNOSTIC USE | JSJ | Substantially Equivalent | |
| K812798 | MOTILITY GI MEDIUM | JSG | Substantially Equivalent | |
| K812797 | SCHAEDLER AGARS | JSG | Substantially Equivalent | |
| K812796 | ANAEROBIC CNA BLOOD AGAR | JSJ | Substantially Equivalent | |
| K812795 | ANAEROBIC BLOOD AGAR | JSG | Substantially Equivalent | |
| K800818 | CHLAMYDOSPORE AGAR | JSH | Substantially Equivalent | |
| K800807 | CORN MEAL AGAR MEDIA | JSJ | Substantially Equivalent | |
| K800334 | MARTIN-LEWIS AGAR | JTY | Substantially Equivalent | |
| K800333 | MODIFIED THAYER-MARTIN X AGAR | JTY | Substantially Equivalent | |
| K800158 | AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD | JSJ | Substantially Equivalent | |
| K800157 | BISMUTH SULFITE AGAR | JSI | Substantially Equivalent | |
| K800156 | STAPHYLOCOCCUS MED. 110 | JSJ | Substantially Equivalent | |
| K792423 | TODD HEWITT BROTH | JSG | Substantially Equivalent | |
| K792596 | TRYPTIC SOY AGAR W/PHENYLETHANOL & | JSJ | Substantially Equivalent | |
| K792595 | SF MEDIUM (SF BROTH, STREPTOCOCCUS | JSJ | Substantially Equivalent | |
| K792594 | TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE. | JSG | Substantially Equivalent | |
| K792593 | PHENYLETHANOL AGAR | JSJ | Substantially Equivalent | |
| K792542 | VOGEL-JOHNSON AGAR | JSH | Substantially Equivalent | |
| K792422 | TETRATHIONATE BROTH BASE | JSJ | Substantially Equivalent | |
| K792421 | DECARBOXYLASE BROTH BASE WITH OR WITH- | JSH | Substantially Equivalent | |
| K792420 | SIM MEDIUM | JSE | Substantially Equivalent | |
| K792544 | LYSINE IRON AGAR | JSH | Substantially Equivalent | |
| K792543 | TRYPTOSE BLOOD AGAR BASE & TRYPTOSE | JSG | Substantially Equivalent | |
| K792425 | DECARBOXYLASE MOELLER BASE WITH OR WITH- | JSE | Substantially Equivalent | |
| K792424 | CHOCOLATE TELLURITE AGAR | JSI | Substantially Equivalent | |
| K792288 | TRYPTONE BROTH (TRYPTOPHANE BROTH) | JSH | Substantially Equivalent | |
| K792287 | KF STREPTOCOCCUS AGAR | JSJ | Substantially Equivalent | |
| K792286 | MR-VP MEDIUM | JSH | Substantially Equivalent | |
| K791946 | OF BASAL MEDIUM | JSH | Substantially Equivalent | |
| K791945 | NITRATE BROTH | JSF | Substantially Equivalent | |
| K791944 | NITRATE AGAR | JSH | Substantially Equivalent | |
| K791943 | NUTRIENT AGAR | JSG | Substantially Equivalent | |
| K791942 | BILE ESCULIN AZIDE AGAR | JSI | Substantially Equivalent | |
| K791941 | PHENOL RED BROTH | JSH | Substantially Equivalent | |
| K791940 | UREA AGAR | JSI | Substantially Equivalent | |
| K791939 | PHENOL RED AGAR | JSH | Substantially Equivalent | |
| K791815 | MUELLER HINTON CHOCOLATE | JTZ | Substantially Equivalent | |
| K791818 | MUELLER HINTON MEDIUM W/SHEEP BLOOD | JTZ | Substantially Equivalent | |
| K791817 | MIO MEDIUM (MOTILITY INDOLE ORNITHINE) | JSH | Substantially Equivalent | |
| K791816 | DC AGAR (DESOXYCHOLATE CITRATE AGAR) | JSI | Substantially Equivalent | |
| K791814 | BILE ESCULIN AGAR | JSH | Substantially Equivalent | |
| K791813 | DNASE TEST AGAR W/METHYL GREEN | JSH | Substantially Equivalent | |
| K791671 | DNASE TEST AGAR | JSH | Substantially Equivalent | |
| K791670 | SABOURAUD AGAR MODIFIED | JSJ | Substantially Equivalent | |
| K791631 | SABOURAUD DEXTROSE AGAR | JSG | Substantially Equivalent | |
| K791630 | BRAIN HEART INFUSION AGAR | JSG | Substantially Equivalent | |
| K791629 | BRAIN HEART CC AGAR | JSJ | Substantially Equivalent | |
| K791628 | BRAIN HEART INFUSION AGAR 5% SHEEP BLOOD | JSG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- 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
- JSICulture Media, Selective And Differential
- JSJCulture Media, Selective And Non-Differential
- JSDCulture Media, Selective Broth
- JSFCulture Media, Single Biochemical Test
- JSRKit, Identification, Dermatophyte
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