Otisville Biotech, Inc.
Walker, MI, US
Otisville Biotech, Inc. appears in FDA device records in Walker, MI. FDA records list 98 510(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
- 98
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 98FDA records hold 98 510(k) clearances for Otisville Biotech, Inc. between 1983 and 1986. The busiest year on record is 1984, with 44. The most recent is 1986, with 43.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 10 |
| 1984 | 44 |
| 1985 | 1 |
| 1986 | 43 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K862400 | BIOTIS KV LAKED BLOOD AGAR | JSJ | Substantially Equivalent | |
| K862399 | BIOTIS SXT AGAR | JSJ | Substantially Equivalent | |
| K862398 | BIOTIS DECARBOXYLASE MEDIA, ORNITHINE | JSF | Substantially Equivalent | |
| K862397 | BIOTIS DECARBOXYLASE MEDIA, LYSINE | JSF | Substantially Equivalent | |
| K862396 | BIOTIS DECARBOXYLASE MEDIA, ARGININE | JSF | Substantially Equivalent | |
| K862395 | BIOTIS DECARBOXYLASE MEDIA, BASE | JSH | Substantially Equivalent | |
| K862394 | BIOTIS MITIS SALIVARIUS | JSI | Substantially Equivalent | |
| K862393 | BIOTIS LITMUS MILK | JSE | Substantially Equivalent | |
| K862392 | BIOTIS MOTILITY TEST MEDIUM | JSF | Substantially Equivalent | |
| K862391 | BIOTIS DESOXYCHOLATE AGAR | JSI | Substantially Equivalent | |
| K862390 | BIOTIS BORDET GENGOU AGAR | KZI | Substantially Equivalent | |
| K862389 | BIOTIS ACETAMIDE AGAR | JSI | Substantially Equivalent | |
| K862388 | BIOTIS TCBS AGAR | JSI | Substantially Equivalent | |
| K862387 | BIOTIS HAEMOPHILUS IDENTIFICATION QUAD | JSH | Substantially Equivalent | |
| K860416 | BIOTIS REGAN-LOWE | JSJ | Substantially Equivalent | |
| K860415 | BIOTIS SIMMON CITRATE AGAR | JSE | Substantially Equivalent | |
| K860414 | BIOTIS ORNITHINE INDOLE MOTILITY MEDIA | JSE | Substantially Equivalent | |
| K860413 | BIOTIS TSI | JSE | Substantially Equivalent | |
| K860412 | BIOTIS SIM MEDIUM | JSE | Substantially Equivalent | |
| K860411 | BIOTIS BHI AGAR | JSG | Substantially Equivalent | |
| K860410 | BIOTIS COOKED MEAT | KZI | Substantially Equivalent | |
| K860409 | BIOTIS COLUMBIA SHEEP BLOOD AGAR | JSG | Substantially Equivalent | |
| K860408 | BIOTIS NUTRIENT AGAR | JSG | Substantially Equivalent | |
| K860407 | BIOTIS ANAEROBIC CNA | JSJ | Substantially Equivalent | |
| K860406 | BIOTIS MIDDLEBROOK 7H9 BROTH | JSJ | Substantially Equivalent | |
| K860405 | BIOTIS TSB WITH 6.5% NACL | JSJ | Substantially Equivalent | |
| K860404 | BIOTIS MIDDLEBROOK 7H10 AGAR SLANT | JSJ | Substantially Equivalent | |
| K860403 | BIOTIS TSA WITH 5% RABBIT BLOOD | JSG | Substantially Equivalent | |
| K860402 | BIOTIS BISMUTH SULFITE AGAR | JSI | Substantially Equivalent | |
| K860401 | BIOTIS TRYPTIC SOY AGAR SLANTS | JSG | Substantially Equivalent | |
| K860399 | BIOTIS TODD HEWITT BROTH | JSG | Substantially Equivalent | |
| K860398 | BIOTIS POTATO DEXTROSE AGAR | JSJ | Substantially Equivalent | |
| K860397 | BIOTIS TSA | JSG | Substantially Equivalent | |
| K860396 | BIOTIS NUTRIENT GELATIN | JTO | Substantially Equivalent | |
| K860395 | BIOTIS HAEMPHILLUS ISOLATION AGAR | JSJ | Substantially Equivalent | |
| K860394 | BIOTIS CETRIMIDE AGAR | JSJ | Substantially Equivalent | |
| K860391 | BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT | JSJ | Substantially Equivalent | |
| K860390 | BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN | JSJ | Substantially Equivalent | |
| K860388 | BIOTIS KF STREPTOCOCCUS AGAR | JSI | Substantially Equivalent | |
| K860386 | BIOTIS SF BROTH | JSI | Substantially Equivalent | |
| K860385 | BIOTIS MAC-MUG | JSI | Substantially Equivalent | |
| K860384 | BIOTIS MODIFIED THAYER MARTIN | JTY | Substantially Equivalent | |
| K860383 | BIOTIS CLOSTRIDIUM DIFFICILE AGAR | JSJ | Substantially Equivalent | |
| K850565 | BIOTIS CHOCOLATE TELLURITE | JSI | Substantially Equivalent | |
| K844195 | BIOTIS ANAEROBIC KBE AGAR | JSI | Substantially Equivalent | |
| K834424 | SFP AGAR PLATES | JSJ | Substantially Equivalent | |
| K834423 | S S AGAR PLATE | JSI | Substantially Equivalent | |
| K834422 | PHENYLETHYL ALCOHOL AGAR PLATE | JSJ | Substantially Equivalent | |
| K834420 | MANNITOL-SALT AGAR USP PLATE | JSI | Substantially Equivalent | |
| K834419 | COLUMBIA CNA AGAR PLATE | JSJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- KZICulture Media, Enriched
- JTYCulture Media, For Isolation Of Pathogenic Neisseria
- JSECulture Media, Multiple Biochemical Test
- JSHCulture Media, Non-Selective And Differential
- JSGCulture Media, Non-Selective And Non-Differential
- JSICulture Media, Selective And Differential
- JSJCulture Media, Selective And Non-Differential
- JSFCulture Media, Single Biochemical Test
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JTLPlasma, Coagulase, Human, Horse And Rabbit
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