510(k) K833356 ยท LCP Assay, Glycosylated Hemoglobin
GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 3, 1983 |
| Received | Sep 28, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833356
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.