510(k) K964527 ยท JIX Calibrator, Multi-Analyte Mixture
N RHEUMATOLOGY STANDARD SL
| Applicant | Behring Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jan 15, 1997 |
| Received | Nov 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964527
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.