510(k) K862371 ยท LCP Assay, Glycosylated Hemoglobin
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
| Applicant | Bio-Rad, Richmond CA, US |
| Decision | Substantially Equivalent, Sep 16, 1986 |
| Received | Jun 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862371
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.