510(k) K013397 ยท JIX Calibrator, Multi-Analyte Mixture
PACIFIC HEMOSTASIS REFERENCE EMULSION
| Applicant | Fisher Diagnostics, Middletown VA, US |
| Decision | Substantially Equivalent, Feb 15, 2002 |
| Received | Oct 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013397
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.