510(k) K991315 ยท JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
MICROALBUSTIX REAGENT STRIPS (OTC)
| Applicant | Bayer Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Nov 12, 1999 |
| Received | Apr 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991315
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.