510(k) K934146 ยท JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
N-ASSAY TIA MICROALBUMIN
| Applicant | Crestat Diagnostics, Inc., Thousand Oaks CA, US |
| Decision | Substantially Equivalent, Jan 11, 1994 |
| Received | Aug 24, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934146
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.