510(k) K961674 ยท LCP Assay, Glycosylated Hemoglobin
ROCHE UNIMATE FRUCTOSAMINE REAGENT
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Sep 27, 1996 |
| Received | May 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961674
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.