510(k) K940971 ยท LCP Assay, Glycosylated Hemoglobin
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
| Applicant | Heraeus Kulzer, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Jul 19, 1994 |
| Received | Mar 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940971
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.