510(k) K111429 ยท JWY Manual Antimicrobial Susceptibility Test Systems
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
| Applicant | Trek Diagnostic Systems, Ltd., Cleveland OH, US |
| Decision | Substantially Equivalent, Aug 18, 2011 |
| Received | May 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111429
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2025 | Remel, Inc Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device Open, Classified |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.