510(k) K082251 ยท DCF Albumin, Antigen, Antiserum, Control
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Apr 8, 2009 |
| Received | Aug 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2017 | Beckman Coulter Inc. Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL
MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems MA Calibrator, is intended for quantitat Terminated |
DCF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.