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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, vanilmandelic, diazo, p-nitroaniline/vanillin
510(k) Number K953077
Device Name PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA,  CA  92821 -6208
Applicant Contact SHERI L HALL
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA,  CA  92821 -6208
Correspondent Contact SHERI L HALL
Regulation Number862.1795
Classification Product Code
CDF  
Subsequent Product Codes
CFF   JQT  
Date Received06/30/1995
Decision Date 01/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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