510(k) K955283 ยท GKA Abnormal Hemoglobin Quantitation
PRIMUS VARIANT SYSTEM PVS99
| Applicant | Primus Corp., Kansas City MO, US |
| Decision | Substantially Equivalent, Mar 1, 1996 |
| Received | Nov 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955283
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2020 | Primus Corporation Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation Terminated |
GKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.