510(k) K053576 ยท JIT Calibrator, Secondary
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
| Applicant | Dade Behring, Inc., P.O. Box 6101, Newark DE, US |
| Decision | Substantially Equivalent, Feb 7, 2006 |
| Received | Dec 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085
Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) 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.