JTY
83 FDA 510(k) clearances · Product code
28 daysmedian time to decision
108 days90th percentile
83clearances measured
FDA profile
- Official device name
- Culture Media, For Isolation Of Pathogenic Neisseria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2410
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 24 · 2025: 35
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| InTray GC (K210511) | Biomed Diagnostics Incorporated | 2021-10-20 |
| INTRAY GC (K993033) | Biomed Diagnostics, Inc. | 1999-12-16 |
| GC BASE W/ 1% GCHI (K954986) | Remel, L.P. | 1996-02-16 |
| CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (K950196) | Bioclinical Systems, Inc. | 1995-06-30 |
| MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (K933122) | Bioclinical Systems, Inc. | 1994-02-09 |
| MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (K933121) | Bioclinical Systems, Inc. | 1994-02-03 |
| THAYER MARTIN, MODIFIED PILL POCKET (K934331) | Hardy Diagnostics | 1993-12-21 |
| TRANSGROW (K934330) | Hardy Diagnostics | 1993-12-17 |
| MARTIN LEWIS WITH LINOCMYCIN (K931864) | Hardy Diagnostics | 1993-12-15 |
| CASMAN MEDIUM BASE (K881527) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PROTEOSE NO. 3 AGAR (K881552) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 (K871541) | Gibco Laboratories Life Technologies, Inc. | 1987-04-29 |
| THAYER MARTIN AGAR (K864253) | Mds Laboratories, Inc. | 1987-03-31 |
| THAYER-MARTIN JEMBEC (K864252) | Mds Laboratories, Inc. | 1987-03-31 |
| GC-LECT(TM) (K864803) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-03 |
| MODIFIED N.Y.C. FERMENTATION MEDIUM BASE (K864078) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-10-31 |
| BIOTIS MODIFIED THAYER MARTIN (K860384) | Otisville Biotech, Inc. | 1986-02-24 |
| THAYER-MARTIN MEDIUM (MOD) (K854275) | R. Kent Richards, Inc. | 1985-11-12 |
| APL MARTIN LEWIS MEDIUM (K853237) | Apl Medical Supplies | 1985-08-19 |
| CHOCOLATE MUELLER HINTON AGAR (K851579) | Preferred Micro-Media | 1985-05-08 |
| THAYER MARTIN AGAR & MODIFIED THAYER AGAR (K851587) | Preferred Micro-Media | 1985-04-30 |
| MARTIN LEWIS AGAR (K850722) | Rapid City Regional Hospital, Inc. | 1985-03-22 |
| CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI (K850732) | Roseville Medical Laboratoriesu | 1985-03-20 |
| MOD THAYER MARTIN MARTIN LEWIS (K850841) | Micro Media Laboratories | 1985-03-20 |
| ONO/CO-TWO (TM) SYSTEMS (K844014) | Micro-Bio-Logics | 1984-10-31 |
| BIOTIS MARTIN LEWIS AGAR (K843817) | Otisville Biotech, Inc. | 1984-10-10 |
| MARTIN-LEWIS AGAR (K841750) | The Montana Deaconess Medical Center | 1984-05-31 |
| CULTURE MEDIUM FOR PATHOGENIC NEISSER (K841833) | Microline Scientific | 1984-05-14 |
| CULTURE MEDIUM FOR PATHOGENIC NEISSER (K840970) | Chatham Biological | 1984-04-13 |
| THAYER-MARTIN AGAR PLATE (K840067) | Otisville Biotech, Inc. | 1984-02-13 |
| CHOCOLATE AGAR GC BASE PLATE (K840065) | Otisville Biotech, Inc. | 1984-02-13 |
| GC-TECT (K840159) | Uti-Tect, Inc. | 1984-01-30 |
| THAYER MARTIN AGAR (K833862) | American Biomedical Corp. | 1983-12-12 |
| NYC-GC MEDIA (K832948) | Otisville Biotech, Inc. | 1983-09-29 |
| TRANSGROW MEDIUM (K832862) | Troy Biologicals, Inc. | 1983-09-26 |
| CHOCOLATE AGAR & THAYER MARTIN AGAR (K832612) | Carroll Biological Corp. | 1983-09-12 |
| MODIFIED NEW YORK MEDIUM (K831359) | Gibco Laboratories Life Technologies, Inc. | 1983-05-18 |
| TILL-U-TEST G.C. GONOCOCUS SLIDE (K831268) | Pasco Laboratories, Inc. | 1983-05-13 |
| BIOCULT - GC CULTURE-PADDLES (K831124) | Orion Diagnostica, Inc. | 1983-05-09 |
| MARTIN-LEWIS AGAR (K830062) | bioMerieux, Inc. | 1983-02-09 |
| THAYER-MARTIN, MODIFIED (K830061) | bioMerieux, Inc. | 1983-02-09 |
| MARTIN & LEMIS AGAR W/VCAT INHIBITOR (K823309) | Troy Biologicals, Inc. | 1982-12-03 |
| NY FERMENTATION MEDIA (K822552) | Gibco Laboratories Life Technologies, Inc. | 1982-09-14 |
| THAYER MARTIN (K821602) | Hardy Media | 1982-07-06 |
| MARTIN-LEWIS/PRONG AGAR (K821551) | Gibco Laboratories Life Technologies, Inc. | 1982-06-22 |
| ISOLATION OF PATHOGENIC NEISSERIA (K820847) | Blue Ridge Media Co. | 1982-04-16 |
| GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) (K812078) | Abbott Laboratories | 1981-07-23 |
| THAYER-MARTIN, GC AGAR BASE (K811645) | Hardy Media | 1981-07-02 |
| CHODOLATE AGAR, ENRICHED (K811479) | Biomedia, Inc. | 1981-06-18 |
| THAYER MARTIN AGAR (K811476) | Biomedia, Inc. | 1981-06-18 |
| LAB-TEK JEMBEC G.C. CULTURE SYSTEM (K811382) | Miles Laboratories, Inc. | 1981-06-16 |
| SELECTIVE GC CULTURE MEDIUM (K811282) | Biolog, Inc. | 1981-06-12 |
| GC CULTURE MEDIUM (K811281) | Biolog, Inc. | 1981-06-12 |
| GC AGAR (K811053) | Acumedia Manufacturers, Inc. | 1981-04-29 |
| THAYER-MARTIN AGAR (K800977) | Quality Assurance Laboratory, Inc. | 1980-05-23 |
| MARTIN-LEWIS AGAR (K800334) | Isle Media and Sterile Products, Inc. | 1980-03-03 |
| MODIFIED THAYER-MARTIN X AGAR (K800333) | Isle Media and Sterile Products, Inc. | 1980-03-03 |
| TRANSGROW (K791554) | American Laboratory Supply, Inc. | 1979-09-17 |
| MODIFIED THAYER-MARTIN AGAR (PLATE) (K791425) | American Laboratory Supply, Inc. | 1979-09-17 |
| MARTIN-LEWIS AGAR (PLATE) (K791557) | American Laboratory Supply, Inc. | 1979-09-17 |
| MARTIN LEWIS AGAR CSI 3169 (K791447) | Clinical Sciences, Inc. | 1979-09-17 |
| MARTIN LEWIS JEMBEC CSI 8872 (K791446) | Clinical Sciences, Inc. | 1979-09-17 |
| MODIFIED THAYER-MARTIN MEDIUM (K791470) | Isle Media and Sterile Products, Inc. | 1979-08-22 |
| CULTURE MEDIA FOR INSOLATION NEISSERIA (K791398) | Isle Media and Sterile Products, Inc. | 1979-08-22 |
| THAYER-MARTIN MEDIUM (K791483) | Isle Media and Sterile Products, Inc. | 1979-08-22 |
| MODIFIED THAYER MARTIN AGAR (K790368) | Biomedia, Inc. | 1979-03-21 |
| MARTIN-LEWIS MEDIUM (K782117) | Prepared Media Laboratory, Inc. | 1979-02-01 |
| CULTURE MEDIA/ISOLA. PATHO. NEISSERIA (K780022) | Diagnostic Culture System | 1978-01-20 |
| MARTIN LEWIS AGAR (PLATE) (K771871) | Granite Diagnostics, Inc. | 1977-10-25 |
| MARTIN LEWIS AGAR (JEMBEC) (K771870) | Granite Diagnostics, Inc. | 1977-10-25 |
| MARTIN LEWIS TRANSGROW (K771872) | Granite Diagnostics, Inc. | 1977-10-25 |
| CULTURE TEST FOR NEISSERIA GONORRHOEAE (K771035) | Miles Laboratories, Inc. | 1977-07-05 |
| IMPROVED THAYER MARTIN (PLATE) (K770874) | Granite Diagnostics, Inc. | 1977-06-08 |
| IMPROVED THAYER-MARTIN MEDIUM (K770925) | Micro-Tech Diagnostic, Inc. | 1977-06-08 |
| IMPROVED THAYER MARTIN (JEMBEC) (K770875) | Granite Diagnostics, Inc. | 1977-06-03 |
| IMPROVED TRANSGROW (K770876) | Granite Diagnostics, Inc. | 1977-06-03 |
| MARTIN-LEWIS AGAR MEDIUM (K770287) | Gibco Laboratories Life Technologies, Inc. | 1977-02-18 |
| IMPROVED THAYER MARTIN MEDIUM (K760598) | Scott Laboratories, Inc. | 1976-10-08 |
| THAYER-MARTIN MEDIUM W/TRIMETHOPRIN L (K760691) | Flow Laboratories, Inc. | 1976-10-07 |
| THAYER-MARTIN MEDIUM WITH ANSIOMYCIN (K760690) | Flow Laboratories, Inc. | 1976-10-07 |
| NEIGON JEMBEC PLATE WITH ANIXOMYCIN (K760693) | Flow Laboratories, Inc. | 1976-10-07 |
| MARTIN-LESTER TRANSGROW W/TRIMETHOPRIN (K760692) | Flow Laboratories, Inc. | 1976-10-07 |
| IMPROVED THAYER MARTIN MEDIUM (K760588) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-10-07 |
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