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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 K952427
Device Name CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
Box 8000
Brea,  CA  92821
Applicant Contact DON W HART
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
Box 8000
Brea,  CA  92821
Correspondent Contact DON W HART
Regulation Number862.1030
Classification Product Code
CKA  
Subsequent Product Codes
CGS   CIT  
Date Received05/24/1995
Decision Date 09/21/1995
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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