LKA
5 FDA 510(k) clearances · Product code
35 daysmedian time to decision
38 days90th percentile
5clearances measured
FDA profile
- Official device name
- Culture Media, Antimicrobial Susceptibility Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1700
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1995: 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 |
|---|---|---|
| IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT (K872687) | I.A.F. Production, Inc. | 1987-08-11 |
| IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD (K872688) | I.A.F. Production, Inc. | 1987-08-11 |
| IAFP MUELLER HINTON AGAR (K872686) | I.A.F. Production, Inc. | 1987-08-11 |
| YEAST BEEF AGAR-ANTIBIOTIC MED.4 (K833218) | Acumedia Manufacturers, Inc. | 1983-10-27 |
| AK AGAR 2 (K833207) | Acumedia Manufacturers, Inc. | 1983-10-27 |
Track LKA automatically
Every clearance here is in the API, with alerts when new ones post.