510(k) K942009 ยท LCP Assay, Glycosylated Hemoglobin
PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY
| Applicant | Primus Corp., Kansas City MO, US |
| Decision | Substantially Equivalent, Sep 14, 1994 |
| Received | Apr 25, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942009
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.