Company ยท US
Otisville Biotech, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1986. Name variants (Inc, Corp, punctuation) are merged.
98510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | 23 |
| JSI | Culture Media, Selective And Differential | 20 |
| JSG | Culture Media, Non-Selective And Non-Differential | 17 |
| JSH | Culture Media, Non-Selective And Differential | 9 |
| JSE | Culture Media, Multiple Biochemical Test | 7 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 5 |
| JSF | Culture Media, Single Biochemical Test | 4 |
| KZI | Culture Media, Enriched | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 1986 | K862400 | BIOTIS KV LAKED BLOOD AGAR Otisville Biotech, Inc. | JSJ |
| Jul 3, 1986 | K862399 | BIOTIS SXT AGAR Otisville Biotech, Inc. | JSJ |
| Jul 3, 1986 | K862398 | BIOTIS DECARBOXYLASE MEDIA, ORNITHINE Otisville Biotech, Inc. | JSF |
| Jul 3, 1986 | K862397 | BIOTIS DECARBOXYLASE MEDIA, LYSINE Otisville Biotech, Inc. | JSF |
| Jul 3, 1986 | K862396 | BIOTIS DECARBOXYLASE MEDIA, ARGININE Otisville Biotech, Inc. | JSF |
| Jul 3, 1986 | K862395 | BIOTIS DECARBOXYLASE MEDIA, BASE Otisville Biotech, Inc. | JSH |
| Jul 3, 1986 | K862394 | BIOTIS MITIS SALIVARIUS Otisville Biotech, Inc. | JSI |
| Jul 3, 1986 | K862393 | BIOTIS LITMUS MILK Otisville Biotech, Inc. | JSE |
| Jul 3, 1986 | K862392 | BIOTIS MOTILITY TEST MEDIUM Otisville Biotech, Inc. | JSF |
| Jul 3, 1986 | K862391 | BIOTIS DESOXYCHOLATE AGAR Otisville Biotech, Inc. | JSI |
| Jul 3, 1986 | K862390 | BIOTIS BORDET GENGOU AGAR Otisville Biotech, Inc. | KZI |
| Jul 3, 1986 | K862389 | BIOTIS ACETAMIDE AGAR Otisville Biotech, Inc. | JSI |
| Jul 3, 1986 | K862388 | BIOTIS TCBS AGAR Otisville Biotech, Inc. | JSI |
| Jul 3, 1986 | K862387 | BIOTIS HAEMOPHILUS IDENTIFICATION QUAD Otisville Biotech, Inc. | JSH |
| Feb 24, 1986 | K860416 | BIOTIS REGAN-LOWE Otisville Biotech, Inc. | JSJ |
| Feb 24, 1986 | K860415 | BIOTIS SIMMON CITRATE AGAR Otisville Biotech, Inc. | JSE |
| Feb 24, 1986 | K860414 | BIOTIS ORNITHINE INDOLE MOTILITY MEDIA Otisville Biotech, Inc. | JSE |
| Feb 24, 1986 | K860413 | BIOTIS TSI Otisville Biotech, Inc. | JSE |
| Feb 24, 1986 | K860412 | BIOTIS SIM MEDIUM Otisville Biotech, Inc. | JSE |
| Feb 24, 1986 | K860411 | BIOTIS BHI AGAR Otisville Biotech, Inc. | JSG |
| Feb 24, 1986 | K860410 | BIOTIS COOKED MEAT Otisville Biotech, Inc. | KZI |
| Feb 24, 1986 | K860409 | BIOTIS COLUMBIA SHEEP BLOOD AGAR Otisville Biotech, Inc. | JSG |
| Feb 24, 1986 | K860408 | BIOTIS NUTRIENT AGAR Otisville Biotech, Inc. | JSG |
| Feb 24, 1986 | K860407 | BIOTIS ANAEROBIC CNA Otisville Biotech, Inc. | JSJ |
| Feb 24, 1986 | K860406 | BIOTIS MIDDLEBROOK 7H9 BROTH Otisville Biotech, Inc. | JSJ |
| Feb 24, 1986 | K860405 | BIOTIS TSB WITH 6.5% NACL Otisville Biotech, Inc. | JSJ |
| Feb 24, 1986 | K860404 | BIOTIS MIDDLEBROOK 7H10 AGAR SLANT Otisville Biotech, Inc. | JSJ |
| Feb 24, 1986 | K860403 | BIOTIS TSA WITH 5% RABBIT BLOOD Otisville Biotech, Inc. | JSG |
| Feb 24, 1986 | K860402 | BIOTIS BISMUTH SULFITE AGAR Otisville Biotech, Inc. | JSI |
| Feb 24, 1986 | K860401 | BIOTIS TRYPTIC SOY AGAR SLANTS Otisville Biotech, Inc. | JSG |
| Feb 24, 1986 | K860399 | BIOTIS TODD HEWITT BROTH Otisville Biotech, Inc. | JSG |
| Feb 24, 1986 | K860398 | BIOTIS POTATO DEXTROSE AGAR Otisville Biotech, Inc. | JSJ |
| Feb 24, 1986 | K860397 | BIOTIS TSA Otisville Biotech, Inc. | JSG |
| Feb 24, 1986 | K860396 | BIOTIS NUTRIENT GELATIN Otisville Biotech, Inc. | JTO |
| Feb 24, 1986 | K860395 | BIOTIS HAEMPHILLUS ISOLATION AGAR Otisville Biotech, Inc. | JSJ |
| Feb 24, 1986 | K860394 | BIOTIS CETRIMIDE AGAR Otisville Biotech, Inc. | JSJ |
| Feb 24, 1986 | K860391 | BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT Otisville Biotech, Inc. | JSJ |
| Feb 24, 1986 | K860390 | BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN Otisville Biotech, Inc. | JSJ |
| Feb 24, 1986 | K860388 | BIOTIS KF STREPTOCOCCUS AGAR Otisville Biotech, Inc. | JSI |
| Feb 24, 1986 | K860386 | BIOTIS SF BROTH Otisville Biotech, Inc. | JSI |
| Feb 24, 1986 | K860385 | BIOTIS MAC-MUG Otisville Biotech, Inc. | JSI |
| Feb 24, 1986 | K860384 | BIOTIS MODIFIED THAYER MARTIN Otisville Biotech, Inc. | JTY |
| Feb 24, 1986 | K860383 | BIOTIS CLOSTRIDIUM DIFFICILE AGAR Otisville Biotech, Inc. | JSJ |
| Mar 13, 1985 | K850565 | BIOTIS CHOCOLATE TELLURITE Otisville Biotech, Inc. | JSI |
| Nov 27, 1984 | K844195 | BIOTIS ANAEROBIC KBE AGAR Otisville Biotech, Inc. | JSI |
| Oct 23, 1984 | K834424 | SFP AGAR PLATES Otisville Biotech, Inc. | JSJ |
| Oct 23, 1984 | K834423 | S S AGAR PLATE Otisville Biotech, Inc. | JSI |
| Oct 23, 1984 | K834422 | PHENYLETHYL ALCOHOL AGAR PLATE Otisville Biotech, Inc. | JSJ |
| Oct 23, 1984 | K834420 | MANNITOL-SALT AGAR USP PLATE Otisville Biotech, Inc. | JSI |
| Oct 23, 1984 | K834419 | COLUMBIA CNA AGAR PLATE Otisville Biotech, Inc. | JSJ |
Newest 50 of 98.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||