JTR
12 FDA 510(k) clearances · Product code
26 daysmedian time to decision
46 days90th percentile
12clearances measured
FDA profile
- Official device name
- Kit, Quality Control For Culture Media
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2480
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1996: 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 |
|---|---|---|
| PROTECT T.M. (K871121) | Pro-Lab, Inc. | 1987-04-14 |
| FEKAL CHECK PARASITOLOGY CONTROL SLIDE (K862914) | Trend Scientific, Inc. | 1986-09-16 |
| KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) | Micro-Bio-Logics | 1986-04-04 |
| INDI KWIK (TM) CO/TWO KIT (K855198) | Micro-Bio-Logics | 1986-01-14 |
| B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS (K842579) | Biological & Environmental Control Laboratories | 1984-07-27 |
| LYFO-DISK MICROORGANISMS (K842129) | Micro-Bio-Logics | 1984-07-03 |
| LYOPHILIZED MICROORGANISMS (K831653) | Austin Biological Laboratories | 1983-07-28 |
| Q-CHECK CULTI-LOOPS (K830133) | Lab Ability, Inc. | 1983-02-09 |
| MICROTECH BACTERIAL CONTROLS (K822954) | Universal Micro Reference Laboratory | 1982-11-16 |
| BIO-CHECK GRAM STAIN CONTROL (K821660) | American Scientific Products | 1982-06-25 |
| SUSCEPTROL (K820064) | American Type Culture Collection | 1982-01-28 |
| GC DISK (K812698) | Remel Co. | 1981-10-06 |
Track JTR automatically
Every clearance here is in the API, with alerts when new ones post.