510(k) K955087 ยท LCP Assay, Glycosylated Hemoglobin
HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 13, 1996 |
| Received | Nov 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955087
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.