Product code JSD
- Device name
- Culture Media, Selective Broth
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2360
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883075 | FASTIDIOUS INOCULUM BROTH | Baxter Healthcare Corp | 1988-08-15 |
| K880107 | CAMPY BROTH | Hardy Media | 1988-03-30 |
| K873324 | SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 | Lakewood Biochemical Co., Inc. | 1987-10-02 |
| K873218 | BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 | Lakewood Biochemical Co., Inc. | 1987-09-23 |
| K871640 | ALKALINE PEPTONE WATER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-05-13 |
| K871447 | TODD HEWITT W/CNA (LIM BROTH) | Remel Co. | 1987-05-13 |
| K870594 | T9802 TSB W/6.5% NACL | Lakewood Biochemical Co., Inc. | 1987-03-30 |
| K853609 | APL TRYPTIC SOY BROTH | Apl Medical Supplies | 1985-09-12 |
| K844547 | TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE | bioMerieux, Inc. | 1985-01-16 |
| K841836 | SELECTIVE CULTURE MED. TRICHOMONAS | Microline Scientific | 1984-05-14 |
| K840971 | SELECTIVE CULTURE MEDIUM | Chatham Biological | 1984-04-13 |
| K841211 | SELECTIVE BROTH | Smith River Biologicals | 1984-04-05 |
| K834013 | SF BROTH | Micro Media Laboratories | 1983-12-27 |
| K834015 | SELENITE BROTH | Micro Media Laboratories | 1983-12-22 |
| K833759 | GROUP STREP BROTH T3472 LIM | Gibco Laboratories Life Technologies, Inc. | 1983-12-16 |
| K832310 | ROGOSA BROTH | Oxoid U.S.A., Inc. | 1983-09-01 |
| K822330 | BACTEC DILUTING FLUID | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-09-02 |
| K822131 | DERMATOPHYTE TEST MEDIUM | Granite Diagnostics, Inc. | 1982-08-03 |
| K820843 | CULTURE MEDIA SELECTIVE BROTH | Blue Ridge Media Co. | 1982-04-16 |
| K820558 | SELENITE BROTH | American Laboratory Supply, Inc. | 1982-03-16 |
| K812451 | CAMPY THIOGLYCOLLATE (TUBE) | Granite Diagnostics, Inc. | 1981-09-23 |
| K811326 | SABOURAUD LIQUID, BROTH MODIFIED | Acumedia Manufacturers, Inc. | 1981-05-28 |
| K791589 | G N BROTH HAJNA | Isle Media and Sterile Products, Inc. | 1979-09-17 |
| K791471 | SELENITE CYSTINE BROTH | Isle Media and Sterile Products, Inc. | 1979-08-22 |
| K791484 | SELENITE BROTH | Isle Media and Sterile Products, Inc. | 1979-08-22 |
| K791481 | LAURYL TRYPTOSE BROTH | Isle Media and Sterile Products, Inc. | 1979-08-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 38053326011772 | LBM CABroth | COPAN ITALIA SPA | 2025-09-22 |
| B645T0641 | EDGE BIOLOGICALS INC | EDGE BIOLOGICALS, INC. | 2025-04-21 |
| B645T0736 | EDGE BIOLOGICALS INC | EDGE BIOLOGICALS, INC. | 2025-04-21 |
| B645T0763 | EDGE BIOLOGICALS INC | EDGE BIOLOGICALS, INC. | 2025-04-21 |
| B645T0781 | EDGE BIOLOGICALS INC | EDGE BIOLOGICALS, INC. | 2025-04-21 |
| B645T2255 | EDGE BIOLOGICALS INC | EDGE BIOLOGICALS, INC. | 2025-04-21 |
| 00816576026883 | N/A | HARDY DIAGNOSTICS | 2024-03-08 |
| 18053326002240 | LBM® TSB Salt | COPAN ITALIA SPA | 2023-06-14 |
| 00848838007781 | REMEL | REMEL, INC. | 2022-12-29 |
| 00848838009082 | REMEL | REMEL, INC. | 2022-12-23 |
| 00848838007217 | REMEL | REMEL, INC. | 2022-12-23 |
| 00848838007194 | REMEL | REMEL, INC. | 2022-12-23 |
| 00848838006029 | REMEL | REMEL, INC. | 2022-12-23 |
| 18053326000345 | LIM Broth | COPAN ITALIA SPA | 2022-12-07 |
| 18053326000338 | LBM® Selenite | COPAN ITALIA SPA | 2022-12-07 |
| 00816576026708 | N/A | HARDY DIAGNOSTICS | 2022-11-15 |
| 00816576029075 | N/A | HARDY DIAGNOSTICS | 2020-09-07 |
| 00819398023610 | N/A | HARDY DIAGNOSTICS | 2020-06-05 |
| 00819398026475 | N/A | HARDY DIAGNOSTICS | 2020-06-05 |
| 00819398022859 | N/A | HARDY DIAGNOSTICS | 2020-06-04 |
| 00819398022415 | N/A | HARDY DIAGNOSTICS | 2020-06-03 |
| 00819398022439 | N/A | HARDY DIAGNOSTICS | 2020-06-03 |
| 00819398021012 | N/A | HARDY DIAGNOSTICS | 2020-06-01 |
| 00819398021234 | N/A | HARDY DIAGNOSTICS | 2020-06-01 |
| 00819398028240 | N/A | HARDY DIAGNOSTICS | 2020-06-01 |
| 00819398020671 | N/A | HARDY DIAGNOSTICS | 2020-05-24 |
| 00819398020756 | N/A | HARDY DIAGNOSTICS | 2020-05-24 |
| 00819398021098 | N/A | HARDY DIAGNOSTICS | 2020-05-24 |
| 00819398020619 | N/A | HARDY DIAGNOSTICS | 2020-05-24 |
| 00819398020596 | N/A | HARDY DIAGNOSTICS | 2020-05-24 |