510(k) K994045 ยท LCP Assay, Glycosylated Hemoglobin
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
| Applicant | Primus Corp., Kansas City MO, US |
| Decision | Substantially Equivalent, Dec 21, 1999 |
| Received | Nov 29, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K994045
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.