510(k) K974491 ยท LCP Assay, Glycosylated Hemoglobin
ACCU-CHEK A1C HEMOGLOBIN TEST
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 13, 1998 |
| Received | Nov 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974491
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.