510(k) K070734 ยท LCP Assay, Glycosylated Hemoglobin
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
| Applicant | Diazyme Laboratories, San Diego CA, US |
| Decision | Substantially Equivalent, Apr 9, 2007 |
| Received | Mar 16, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070734
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2008 | Alfa Wassermann, Inc. ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators.
Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitr Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.