510(k) K051321 ยท LCP Assay, Glycosylated Hemoglobin
INVIEW
| Applicant | Metrika, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 13, 2005 |
| Received | May 20, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051321
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2007 | Metrika Inc A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.