510(k) K885053 ยท JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
BIOTROL URINE PROTEINS REAGENT
| Applicant | Biotrol, USA, Inc., Westchester PA, US |
| Decision | Substantially Equivalent, Jan 30, 1989 |
| Received | Dec 7, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885053
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.