510(k) K934070 ยท LCP Assay, Glycosylated Hemoglobin
TINA-QUANT HEMOGLOBIN A1C
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 11, 1994 |
| Received | Aug 20, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934070
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.