510(k) K990992 ยท LCP Assay, Glycosylated Hemoglobin
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 30, 1999 |
| Received | Mar 24, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990992
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.