510(k) K832087 ยท LCP Assay, Glycosylated Hemoglobin
TITAN GEL GLYCO-HEME SYSTEM
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 24, 1983 |
| Received | Jun 28, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832087
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.