510(k) K884315 ยท LCP Assay, Glycosylated Hemoglobin
LABILE LYSING REAGENT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Dec 27, 1988 |
| Received | Oct 13, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884315
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.