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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 K904220
Device Name SYNCHRON CX4-CE
Applicant
Beckman
200 S. Kraemer Blvd.
W-337
Brea,  CA  92621
Applicant Contact WILLIAM T RYAN
Correspondent
Beckman
200 S. Kraemer Blvd.
W-337
Brea,  CA  92621
Correspondent Contact WILLIAM T RYAN
Regulation Number862.2160
Classification Product Code
JJE  
Date Received09/12/1990
Decision Date 10/15/1990
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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