LTW
16 FDA 510(k) clearances · Product code
93 daysmedian time to decision
196 days90th percentile
16clearances measured
FDA profile
- Official device name
- Susceptibility Test Cards, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- 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 |
|---|---|---|
| MIC-CONCEPT SYSTEM (K852613) | Microtech Medical Systems, Inc. | 1985-09-20 |
| PRECEPT CEFOPERAZONE (K853596) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT CEFTRIAXONE (K853273) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT TM CARBENICILLIN (K853685) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT METHICILLIN (K853772) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT TM MOXALACTAM (K853689) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT TM AMIKACIN (K853686) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT KANAMYCIN (K853684) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT NETILMICIN 32-13 (K853687) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT TM TOBRAMYCIN (K853688) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT ERYTHROMYCIN (K853053) | Austin Biological Laboratories | 1985-08-29 |
| PRECEPT AVGMENTIN (K853263) | Austin Biological Laboratories | 1985-08-29 |
| API UNISCEPT KB (K850347) | Analytical Products, Inc. | 1985-03-26 |
| API UNISCEPT MIC 100UL (K844159) | Analytical Products, Inc. | 1984-12-14 |
| SCEPTOR BETA-LACTAM PLUS MIC PANEL (K844231) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-07 |
| API UNISCEPT KB (K843733) | Analytical Products, Inc. | 1984-10-24 |
Track LTW automatically
Every clearance here is in the API, with alerts when new ones post.