510(k) K900718 ยท LCP Assay, Glycosylated Hemoglobin
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Jun 12, 1990 |
| Received | Feb 14, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900718
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.