510(k) K013643 ยท JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
AUSAM TOTAL ALBUMIN ASSAY
| Applicant | Ausam Biotecthnologies, Inc., New York NY, US |
| Decision | Substantially Equivalent, Aug 14, 2003 |
| Received | Nov 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013643
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.