510(k) K102638 ยท JIT Calibrator, Secondary
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Nov 30, 2010 |
| Received | Sep 14, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K102638
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.