510(k) K012410 ยท LCP Assay, Glycosylated Hemoglobin
INFINITY HBA KIT, MODELS 537-A, 537-B
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Oct 26, 2001 |
| Received | Jul 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012410
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.