SYNCHRON CX5CE CLINICAL ANALYZER

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Cx5ce Clinical Analyzer.

Pre-market Notification Details

Device IDK926060
510k NumberK926060
Device Name:SYNCHRON CX5CE CLINICAL ANALYZER
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
ContactDon W Hart
CorrespondentDon W Hart
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-01
Decision Date1993-02-12

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