510(k) K993131 ยท LCP Assay, Glycosylated Hemoglobin
NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
| Applicant | Primus, Inc., Kansas City MO, US |
| Decision | Substantially Equivalent, May 22, 2000 |
| Received | Sep 20, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993131
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.