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510(k) Premarket Notification Database

Device Classification Name acid, vanilmandelic, diazo, p-nitroaniline/vanillin
510(k) NumberK953077
Device NamePARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM
Applicant
BECKMAN INSTRUMENTS, INC.
200 south kraemer blvd.
w-337
brea,  CA  92821 620
Contactsheri 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 (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Statement/Summary/Purged Status Summary only
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 02/06/2009

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