510(k) K092911 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Apr 26, 2010 |
| Received | Sep 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092911
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.