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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, Micro, For Clinical Use
510(k) Number K942676
Device Name SYNCHRON CX3 DELTA
Applicant
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd.
Brea,  CA  92621
Applicant Contact SHERI HALL
Correspondent
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd.
Brea,  CA  92621
Correspondent Contact SHERI HALL
Regulation Number862.2170
Classification Product Code
JJF  
Subsequent Product Codes
CDQ   CEK   JFN  
Date Received06/06/1994
Decision Date 11/02/1994
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
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