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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nadh oxidation/nad reduction, alt/sgpt
510(k) Number K883181
Device Name SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
Original Applicant
BECKMAN INSTRUMENTS, INC.
200 south kraemer blvd., w-337
box 8000
brea,  CA  92622 8000
Original Contact william ryan
Regulation Number862.1030
Classification Product Code
CKA  
Date Received07/27/1988
Decision Date 09/19/1988
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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