JSA
8 FDA 510(k) clearances · Product code
10 daysmedian time to decision
41 days90th percentile
8clearances measured
FDA profile
- Official device name
- Culture Media, Antibiotic Assay
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2350
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1994: 1
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 |
|---|---|---|
| ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR (K881534) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR (K881536) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ANTIBIOTIC MEDIUM #19 (K881537) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR (K881538) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ANTIBIOTIC MEDIUM #6 (K881535) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| SEED AGAR (K832577) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| BASE AGAR (K832576) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| ANTIBIOTIC ASSAY BROTH (K832575) | Acumedia Manufacturers, Inc. | 1983-09-12 |
Track JSA automatically
Every clearance here is in the API, with alerts when new ones post.