510(k) K951361 ยท LCP Assay, Glycosylated Hemoglobin
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
| Applicant | Heraeus Kulzer, Inc., Mishawaka IN, US |
| Decision | Substantially Equivalent, May 5, 1995 |
| Received | Mar 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2024 | Siemens Healthcare Diagnostics, Inc. DCA Systems HbA1c Reagent Kit Open, Classified |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.