510(k) K965035 ยท JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Apr 17, 1997 |
| Received | Dec 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965035
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.