510(k) K896830 ยท LCP Assay, Glycosylated Hemoglobin
OPTIMATE HEMOGLOBIN A1C
| Applicant | Heraeus Kulzer, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Sep 11, 1990 |
| Received | Dec 4, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896830
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.