510(k) K896582 ยท LCP Assay, Glycosylated Hemoglobin
DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)
| Applicant | Primus, Inc., Kansas City MO, US |
| Decision | Substantially Equivalent, Jun 28, 1990 |
| Received | Nov 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896582
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.