510(k) K933258 ยท KLS Enzyme Immunoassay, Theophylline
VIDAS THEOPHYLLINE(THEO)
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Aug 16, 1993 |
| Received | Jul 6, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933258
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.