510(k) K001810 ยท JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
| Applicant | Flexsite Diagnostics, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Aug 14, 2000 |
| Received | Jun 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001810
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.