JSD
26 FDA 510(k) clearances · Product code
30 daysmedian time to decision
51 days90th percentile
26clearances measured
FDA profile
- Official device name
- Culture Media, Selective Broth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1995: 1 · 2002: 2 · 2006: 24
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 |
|---|---|---|
| FASTIDIOUS INOCULUM BROTH (K883075) | Baxter Healthcare Corp | 1988-08-15 |
| CAMPY BROTH (K880107) | Hardy Media | 1988-03-30 |
| SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (K873324) | Lakewood Biochemical Co., Inc. | 1987-10-02 |
| BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 (K873218) | Lakewood Biochemical Co., Inc. | 1987-09-23 |
| ALKALINE PEPTONE WATER (K871640) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-05-13 |
| TODD HEWITT W/CNA (LIM BROTH) (K871447) | Remel Co. | 1987-05-13 |
| T9802 TSB W/6.5% NACL (K870594) | Lakewood Biochemical Co., Inc. | 1987-03-30 |
| APL TRYPTIC SOY BROTH (K853609) | Apl Medical Supplies | 1985-09-12 |
| TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (K844547) | bioMerieux, Inc. | 1985-01-16 |
| SELECTIVE CULTURE MED. TRICHOMONAS (K841836) | Microline Scientific | 1984-05-14 |
| SELECTIVE CULTURE MEDIUM (K840971) | Chatham Biological | 1984-04-13 |
| SELECTIVE BROTH (K841211) | Smith River Biologicals | 1984-04-05 |
| SF BROTH (K834013) | Micro Media Laboratories | 1983-12-27 |
| SELENITE BROTH (K834015) | Micro Media Laboratories | 1983-12-22 |
| GROUP STREP BROTH T3472 LIM (K833759) | Gibco Laboratories Life Technologies, Inc. | 1983-12-16 |
| ROGOSA BROTH (K832310) | Oxoid U.S.A., Inc. | 1983-09-01 |
| BACTEC DILUTING FLUID (K822330) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-09-02 |
| DERMATOPHYTE TEST MEDIUM (K822131) | Granite Diagnostics, Inc. | 1982-08-03 |
| CULTURE MEDIA SELECTIVE BROTH (K820843) | Blue Ridge Media Co. | 1982-04-16 |
| SELENITE BROTH (K820558) | American Laboratory Supply, Inc. | 1982-03-16 |
| CAMPY THIOGLYCOLLATE (TUBE) (K812451) | Granite Diagnostics, Inc. | 1981-09-23 |
| SABOURAUD LIQUID, BROTH MODIFIED (K811326) | Acumedia Manufacturers, Inc. | 1981-05-28 |
| G N BROTH HAJNA (K791589) | Isle Media and Sterile Products, Inc. | 1979-09-17 |
| LAURYL TRYPTOSE BROTH (K791481) | Isle Media and Sterile Products, Inc. | 1979-08-22 |
| SELENITE BROTH (K791484) | Isle Media and Sterile Products, Inc. | 1979-08-22 |
| SELENITE CYSTINE BROTH (K791471) | Isle Media and Sterile Products, Inc. | 1979-08-22 |
Track JSD automatically
Every clearance here is in the API, with alerts when new ones post.