510(k) K935519 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST FOR AMPICILLIN/SULBACTAM 2/1
| Applicant | Ab Biodisk North America, Inc., S-17136 Solna, Sweden, SE |
| Decision | Substantially Equivalent, Nov 4, 1994 |
| Received | Nov 18, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935519
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.