510(k) K991850 ยท LCP Assay, Glycosylated Hemoglobin
SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
| Applicant | Biosafe Laboratories, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Nov 26, 1999 |
| Received | Jun 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991850
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.