510(k) K883181 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Sep 19, 1988 |
| Received | Jul 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883181
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2012 | Beckman Coulter Inc. Synchron CX Immuno-Protein Cal, part number: 442840,
other product code: CKA
The Beckman Coulter SYNCHRON CX Immune Protein Calibrator Set, in conjunction with SYNCHRON Immuno Protein Reagents, is Terminated |
JIT | None listed |
| Mar 9, 2011 | Beckman Coulter Inc. GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640;
SYNCHRON and UniCel Systems and Part Numbers:
Synchron LX20, Part Number: 466200,
Terminated |
CEM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.