510(k) K013465 ยท LCP Assay, Glycosylated Hemoglobin
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
| Applicant | Diabetes Technologies, Inc., Thomasville GA, US |
| Decision | Substantially Equivalent, Jan 22, 2002 |
| Received | Oct 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013465
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.