510(k) K970932 ยท JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
ORGENTEC MICRO-ALBUMIN EIA ASSAY
| Applicant | American Laboratory Products Co., Ltd., Windham NH, US |
| Decision | Substantially Equivalent, Apr 8, 1997 |
| Received | Feb 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970932
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.