510(k) K012470 ยท JIX Calibrator, Multi-Analyte Mixture
MODIFICATION TO N PROTEIN STANDARD SL
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 28, 2001 |
| Received | Aug 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012470
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2017 | CSL Behring GmbH SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073 Terminated |
CHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.