510(k) K902455 ยท LCP Assay, Glycosylated Hemoglobin
ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
| Applicant | Analytical Control Systems, Inc., Fishers IN, US |
| Decision | Substantially Equivalent, Jul 24, 1990 |
| Received | Jun 4, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902455
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.