510(k) K970336 ยท JIT Calibrator, Secondary
MMB CALIBRATOR
| Applicant | Dade Chemistry Systems, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Mar 3, 1997 |
| Received | Jan 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970336
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2013 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420)
The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase M Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.