510(k) K911613 ยท LCR Fluorescent Immunoassay, Tobramycin
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
| Applicant | Exmoor Plastics , Ltd., Taunton, GB |
| Decision | Substantially Equivalent, Jun 28, 1991 |
| Received | Apr 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911613
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.