510(k) K012921 ยท JWY Manual Antimicrobial Susceptibility Test Systems
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
| Applicant | Trek Diagnostic Systems, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Nov 2, 2001 |
| Received | Aug 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012921
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.