510(k) K983253 ยท LCP Assay, Glycosylated Hemoglobin
PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
| Applicant | Medisense, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Nov 20, 1998 |
| Received | Sep 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983253
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.