SYNCHRON CX(TM)5 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 Cx(tm)5 Clinical Analyzer.

Pre-market Notification Details

Device IDK881495
510k NumberK881495
Device Name:SYNCHRON CX(TM)5 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
ContactWilliam T Ryan
CorrespondentWilliam T Ryan
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 Received1988-04-08
Decision Date1988-06-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.