510(k) K141750 ยท LCP Assay, Glycosylated Hemoglobin
HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
| Applicant | Infopia Co, Ltd., Fullerton CA, US |
| Decision | Substantially Equivalent, Jul 24, 2014 |
| Received | Jun 30, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141750
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.