DID
5 FDA 510(k) clearances · Product code
16 daysmedian time to decision
66 days90th percentile
5clearances measured
FDA profile
- Official device name
- Bacillus Subtilis Microbiology Assay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EMIT-ST URINE COCAINE METABOLITE ASSAY (K820773) | Syva Co. | 1982-04-08 |
| PHENYTOIN REAGENT TEST KIT (K802038) | Beckman Instruments, Inc. | 1980-10-23 |
| BIO-MONITOR TOBRAMYCIN (K780950) | Monitor Science Corp. | 1978-08-14 |
| TOBRAMYCIN 125I RIA KIT (K780182) | New England Nuclear | 1978-02-13 |
| AMINOGLYCOSIDE TEST SYSTEM (K780048) | Nichols Institute Diagnostics | 1978-01-20 |
Track DID automatically
Every clearance here is in the API, with alerts when new ones post.