510(k) K014173 ยท DKJ Colorimetry, Salicylate
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 15, 2002 |
| Received | Dec 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2017 | Beckman Coulter Inc. Salicylate Reagent (SALY 2 x 45), Catalog No. 378194.
Intended for quantitative determination of salicylate concentration in human serum or plasma. Terminated |
DKJ | None listed |
| Sep 30, 2009 | Beckman Coulter Inc SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194.
SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Terminated |
DKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.