510(k) K894169 ยท JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
BIOTEL MICROALBUMINURIA (TM)
| Applicant | American Diagnostic Corp., Oak Brook IL, US |
| Decision | Substantially Equivalent, Sep 18, 1989 |
| Received | Jun 15, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894169
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.