510(k) K881863 ยท LCP Assay, Glycosylated Hemoglobin
REP GLYCO SYSTEM
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Sep 30, 1988 |
| Received | May 3, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881863
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.