JSH
146 FDA 510(k) clearances · Product code
26 daysmedian time to decision
49 days90th percentile
146clearances measured
FDA profile
- Official device name
- Culture Media, Non-Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2021: 42 · 2025: 20
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 |
|---|---|---|
| DNASE TEST AGAR (K881486) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| UREA AGAR BASE (K881559) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| RUSSELL DOUBLE SUGAR AGAR (K881553) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| UREA BROTH (K881560) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PHENOL RED BROTH BASE (K881551) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| FLO AGAR (K881540) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MOELLERS DECARBOXYLASE, BASE (K880121) | Hardy Media | 1988-03-31 |
| OF MEDIUM BASE (K880117) | Hardy Media | 1988-03-30 |
| ACTINOMYCETE DIFFERENTIAL MEDIA (K873270) | Central Media | 1987-11-04 |
| MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (K873263) | Central Media | 1987-10-28 |
| SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084 (K873411) | Lakewood Biochemical Co., Inc. | 1987-10-06 |
| MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 (K873704) | Lakewood Biochemical Co., Inc. | 1987-10-02 |
| LYSINE IRON AGAR (LIA) PRODUCT #T3046 (K873703) | Lakewood Biochemical Co., Inc. | 1987-10-02 |
| IAFP MAC CONKEY AGAR (K872670) | I.A.F. Production, Inc. | 1987-08-11 |
| MUCATE AGAR, SLANTS AND MUCATE BROTH (K872020) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-06-02 |
| SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM (K871855) | Gibco Laboratories Life Technologies, Inc. | 1987-05-26 |
| ARYLSULFATASE BROTH (K871701) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-05-20 |
| HEMOPHILUS ID QUAD PLATE (K870636) | Hardy Media | 1987-04-14 |
| BIGGY AGAR (K870651) | Hardy Media | 1987-04-14 |
| CLED AGAR (K871095) | bioMerieux, Inc. | 1987-04-03 |
| CLED AGAR WITH ANDRADES INDICATOR (K864239) | Mds Laboratories, Inc. | 1987-03-31 |
| THERMOSTABLE NUCLEASE TEST AGAR (K864454) | Dimed, Intl. | 1986-11-28 |
| THERMONUCLEASE AGAR W/TOLUIDINE BLUE (K864205) | Remel Co. | 1986-11-24 |
| TRYCOPHYTON AGARS (K864100) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-10-31 |
| STARCH AGAR W/BROM CRESOL PURPLE (K863599) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 |
| MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM (K863600) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 |
| XANTHINE/TYROSINE/CASEIN AGAR (K863572) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 |
| BIRD SEED AGAR (K863573) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 |
| TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR (K863523) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-19 |
| BIOTIS DECARBOXYLASE MEDIA, BASE (K862395) | Otisville Biotech, Inc. | 1986-07-03 |
| BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (K862387) | Otisville Biotech, Inc. | 1986-07-03 |
| PSEUDOMONAS AGAR P (MEDIUM A) (K860750) | Gibco Laboratories Life Technologies, Inc. | 1986-03-10 |
| APL SIM MEDIUM (K853618) | Apl Medical Supplies | 1985-09-16 |
| APL MOTILITY INDOLE ORNITHINE AGAR (K853610) | Apl Medical Supplies | 1985-09-16 |
| APL TRIPLE SUGAR IRON AGAR (K853619) | Apl Medical Supplies | 1985-09-16 |
| APL BILE ESCULIN/AZIDE AGAR (K853615) | Apl Medical Supplies | 1985-09-06 |
| APL GN BROTH (K853613) | Apl Medical Supplies | 1985-09-06 |
| APL CHLAMYDOSPORE AGAR (K853616) | Apl Medical Supplies | 1985-09-06 |
| APL DNASE TEST AGAR (K853612) | Apl Medical Supplies | 1985-09-06 |
| APL FLUID THIOGLYCOLLATE MEDIUM (K853614) | Apl Medical Supplies | 1985-09-06 |
| DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR (K853336) | Hardy Media | 1985-08-29 |
| CLED AGAR (K852578) | American Laboratory Supply, Inc. | 1985-07-12 |
| DRI-FORM PSEUDOMONAS AGAR F (K852064) | Gibco Laboratories Life Technologies, Inc. | 1985-06-04 |
| TRIPLE SUGAR IRON AGAR (K851597) | Preferred Micro-Media | 1985-05-13 |
| SIMMONS CITRATE AGAR (K851595) | Preferred Micro-Media | 1985-05-13 |
| SIM MEDIUM (K851596) | Preferred Micro-Media | 1985-05-13 |
| BIGGY AGAR NICKERSONS MEDIUM (K851576) | Preferred Micro-Media | 1985-05-09 |
| UREA AGAR (K851602) | Preferred Micro-Media | 1985-05-08 |
| OXIDATIVE FORMENTIVE MEDIUM (K851344) | Micro Media Laboratories | 1985-04-22 |
| BROM CRESOL PURPLE STARCH (K851343) | Micro Media Laboratories | 1985-04-19 |
| PHENYLALANINE AGAR (K851346) | Micro Media Laboratories | 1985-04-19 |
| PURPLE BROTH (K851345) | Micro Media Laboratories | 1985-04-19 |
| KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E (K850721) | Rapid City Regional Hospital, Inc. | 1985-03-22 |
| DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR (K850719) | Rapid City Regional Hospital, Inc. | 1985-03-22 |
| CORN MEAL AGAR (K850718) | Rapid City Regional Hospital, Inc. | 1985-03-20 |
| V AGAR (K850844) | Micro Media Laboratories | 1985-03-20 |
| UREA AGAR (K844548) | bioMerieux, Inc. | 1985-01-16 |
| V AGAR (K844513) | bioMerieux, Inc. | 1985-01-07 |
| DTM AGAR (K844514) | bioMerieux, Inc. | 1985-01-07 |
| SIM MEDIUM (K844521) | bioMerieux, Inc. | 1985-01-07 |
| HAEMOPHILUS I.D. QUAD (K844519) | bioMerieux, Inc. | 1985-01-07 |
| SIMMONS CITRATE AGAR (K844532) | bioMerieux, Inc. | 1985-01-07 |
| TRIPLE SUGAR IRON (K844531) | bioMerieux, Inc. | 1985-01-07 |
| SF BROTH (K844522) | bioMerieux, Inc. | 1985-01-07 |
| STARCH HYDROLYSIS AGAR W/INDICATOR (K844516) | bioMerieux, Inc. | 1985-01-07 |
| KLIGER IRON AGAR (K844520) | bioMerieux, Inc. | 1985-01-07 |
| BIOTIS SEVEN H 11 AGAR (K843771) | Otisville Biotech, Inc. | 1984-10-10 |
| BIOTIS LOWENSTEIN-JENSEN MEDIA (K843769) | Otisville Biotech, Inc. | 1984-10-10 |
| TRIPLE SUGAR IRON (K842850) | Anarobe Systems | 1984-08-17 |
| ORNITHINE INDOLE MOTILITY (K842851) | Anarobe Systems | 1984-08-07 |
| DIFFERENTIAL CULTURE MED. LEVINE EMB (K841843) | Microline Scientific | 1984-05-31 |
| NON-SELECTIVE & DIFFERENTIAL (K841206) | Smith River Biologicals | 1984-04-17 |
| ESCULIN AGAR PLATE (K840073) | Otisville Biotech, Inc. | 1984-02-03 |
| DNASE AGAR W/TOLUDINE BLUE PLATE (K840071) | Otisville Biotech, Inc. | 1984-02-03 |
| BILE ESCULIN AGAR PLATE (K840068) | Otisville Biotech, Inc. | 1984-01-30 |
| EGG YOLK AGAR PLATE (K840070) | Otisville Biotech, Inc. | 1984-01-30 |
| ACETAMIDE AGAR SLANTS (K834509) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-01-27 |
| MIDDLEBROOK & COHN 7H10 AGAR BASE (K834205) | Acumedia Manufacturers, Inc. | 1984-01-03 |
| MIDDLEBROOK & COHN 7H11 AGAR BASE (K834204) | Acumedia Manufacturers, Inc. | 1984-01-03 |
| SIMMONS CITRATE AGAR (K834009) | Micro Media Laboratories | 1983-12-22 |
| JH PEPTONE AGAR (K833291) | Acumedia Manufacturers, Inc. | 1983-11-28 |
| KLIGLER IRON AGAR (K833213) | Acumedia Manufacturers, Inc. | 1983-10-27 |
| MOTILITY TEST MEDIUM (K833216) | Acumedia Manufacturers, Inc. | 1983-10-27 |
| SIMMONS CITRATE AGAR (K833201) | Acumedia Manufacturers, Inc. | 1983-10-27 |
| MOELLER DECARBOXYLASE BROTH (K833202) | Acumedia Manufacturers, Inc. | 1983-10-27 |
| MR-VP BROTH (K833208) | Acumedia Manufacturers, Inc. | 1983-10-27 |
| TECH AGAR (K833206) | Acumedia Manufacturers, Inc. | 1983-10-27 |
| AGAR PLATE XLD (K832532) | Otisville Biotech, Inc. | 1983-09-29 |
| BTB LACTOSE AGAR (K832574) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| MACCONKEY AGAR MEDIA (K832616) | Carroll Biological Corp. | 1983-09-12 |
| C.L.E.D. MEDIUM (K832573) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| EGG YOLK AGAR (K831827) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-07-26 |
| LEVINE EMB AGAR (K830073) | bioMerieux, Inc. | 1983-02-09 |
| ACETAMIDE AGAR (K830020) | Gibco Laboratories Life Technologies, Inc. | 1983-02-07 |
| COLUMBIA V AGAR W/5% HUMAN BLOOD (K823311) | Troy Biologicals, Inc. | 1982-12-15 |
| ACETAMIDE AGAR SLANT (K823070) | Granite Diagnostics, Inc. | 1982-11-05 |
| H BROTH (K823091) | Granite Diagnostics, Inc. | 1982-11-05 |
| RICE EXTRACT AGAR (K823071) | Granite Diagnostics, Inc. | 1982-11-05 |
| V AGAR (K822702) | Granite Diagnostics, Inc. | 1982-09-30 |
| HAEMOPHILUS ID PLATE (K822377) | Granite Diagnostics, Inc. | 1982-08-25 |
Track JSH automatically
Every clearance here is in the API, with alerts when new ones post.