Product code JTY
- Device name
- Culture Media, For Isolation Of Pathogenic Neisseria
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.2410
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210511 | InTray GC | Biomed Diagnostics Incorporated | 2021-10-20 |
| K993033 | INTRAY GC | Biomed Diagnostics, Inc. | 1999-12-16 |
| K954986 | GC BASE W/ 1% GCHI | Remel, L.P. | 1996-02-16 |
| K950196 | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | Bioclinical Systems, Inc. | 1995-06-30 |
| K933122 | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR | Bioclinical Systems, Inc. | 1994-02-09 |
| K933121 | MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR | Bioclinical Systems, Inc. | 1994-02-03 |
| K934331 | THAYER MARTIN, MODIFIED PILL POCKET | Hardy Diagnostics | 1993-12-21 |
| K934330 | TRANSGROW | Hardy Diagnostics | 1993-12-17 |
| K931864 | MARTIN LEWIS WITH LINOCMYCIN | Hardy Diagnostics | 1993-12-15 |
| K881552 | PROTEOSE NO. 3 AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881527 | CASMAN MEDIUM BASE | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K871541 | MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 | Gibco Laboratories Life Technologies, Inc. | 1987-04-29 |
| K864253 | THAYER MARTIN AGAR | Mds Laboratories, Inc. | 1987-03-31 |
| K864252 | THAYER-MARTIN JEMBEC | Mds Laboratories, Inc. | 1987-03-31 |
| K864803 | GC-LECT(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-03 |
| K864078 | MODIFIED N.Y.C. FERMENTATION MEDIUM BASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-10-31 |
| K860384 | BIOTIS MODIFIED THAYER MARTIN | Otisville Biotech, Inc. | 1986-02-24 |
| K854275 | THAYER-MARTIN MEDIUM (MOD) | R. Kent Richards, Inc. | 1985-11-12 |
| K853237 | APL MARTIN LEWIS MEDIUM | Apl Medical Supplies | 1985-08-19 |
| K851579 | CHOCOLATE MUELLER HINTON AGAR | Preferred Micro-Media | 1985-05-08 |
| K851587 | THAYER MARTIN AGAR & MODIFIED THAYER AGAR | Preferred Micro-Media | 1985-04-30 |
| K850722 | MARTIN LEWIS AGAR | Rapid City Regional Hospital, Inc. | 1985-03-22 |
| K850841 | MOD THAYER MARTIN MARTIN LEWIS | Micro Media Laboratories | 1985-03-20 |
| K850732 | CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI | Roseville Medical Laboratoriesu | 1985-03-20 |
| K844014 | ONO/CO-TWO (TM) SYSTEMS | Micro-Bio-Logics | 1984-10-31 |
| K843817 | BIOTIS MARTIN LEWIS AGAR | Otisville Biotech, Inc. | 1984-10-10 |
| K841750 | MARTIN-LEWIS AGAR | The Montana Deaconess Medical Center | 1984-05-31 |
| K841833 | CULTURE MEDIUM FOR PATHOGENIC NEISSER | Microline Scientific | 1984-05-14 |
| K840970 | CULTURE MEDIUM FOR PATHOGENIC NEISSER | Chatham Biological | 1984-04-13 |
| K840067 | THAYER-MARTIN AGAR PLATE | Otisville Biotech, Inc. | 1984-02-13 |
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| 00816576028948 | NA | HARDY DIAGNOSTICS | 2020-03-31 |
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| 30382902977156 | BD BBL™ GC-Lect™ Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902216231 | BD BBL™ Chocolate II Agar/Modified Thayer-Martin Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902215678 | BD BBL™ Modified Thayer-Martin (MTM II) Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902215579 | BD BBL™ Martin-Lewis Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902213032 | BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902213025 | BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902211694 | BD BBL™ Chocolate II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902962718 | BD BBL™ Chocolate II Agar with Bacitracin | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902215586 | BD BBL™ Martin-Lewis Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902215685 | BD BBL™ Modified Thayer-Martin (MTM II) Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902212677 | BD BBL™ Chocolate II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902977152 | BD BBL™ GC-Lect™ Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902962714 | BD BBL™ Chocolate II Agar with Bacitracin | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902216237 | BD BBL™ Chocolate II Agar/Modified Thayer-Martin Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902215681 | BD BBL™ Modified Thayer-Martin (MTM II) Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902215674 | BD BBL™ Modified Thayer-Martin (MTM II) Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902215582 | BD BBL™ Martin-Lewis Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902215575 | BD BBL™ Martin-Lewis Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902213038 | BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902213021 | BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| M20210951 | MARTIN LEWIS AGAR | Healthlink | 2016-09-24 |
| M202V8001 | MARTIN LEWIS G.C. SYSTEM | Healthlink | 2016-09-24 |
| M2027657ML2 | MARTIN LEWIS G.C. SYSTEM | Healthlink | 2016-09-24 |
| M202173811 | JEMBEC MOD THAYER MARTIN | Healthlink | 2016-09-24 |
| M20217371 | JEMBEC MARTIN LEWIS | Healthlink | 2016-09-24 |
| M20211001 | MODIFIED THAYER MARTIN | Healthlink | 2016-09-24 |
| B08810800 | InTray™ GC | BIO-MED DIAGNOSTICS, INC. | 2016-09-21 |