510(k) K971458 ยท JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
| Applicant | Diagnostic Specialties, Metuchen NJ, US |
| Decision | Substantially Equivalent, Sep 2, 1997 |
| Received | Apr 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971458
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.