510(k) K912613 ยท JWY Manual Antimicrobial Susceptibility Test Systems
GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)
| Applicant | Sensititre Microbiology A Div. of Radiometer, Westlake OH, US |
| Decision | Substantially Equivalent, Aug 22, 1991 |
| Received | Jun 12, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912613
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.