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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K951189
Device Name SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821 -6208
Applicant Contact SHERI HALL
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821 -6208
Correspondent Contact SHERI HALL
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CDQ   CEK   JFN   JJF  
Date Received03/16/1995
Decision Date 06/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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