510(k) K884184 ยท LCP Assay, Glycosylated Hemoglobin
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 28, 1989 |
| Received | Oct 4, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884184
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.