510(k) K061818 ยท JIT Calibrator, Secondary
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 18, 2006 |
| Received | Jun 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061818
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator
The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System. Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.