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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apolipoproteins
510(k) Number K970314
Device Name SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Applicant Contact KATHLEEN M JAKER
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Correspondent Contact KATHLEEN M JAKER
Regulation Number862.1475
Classification Product Code
MSJ  
Subsequent Product Code
JIT  
Date Received01/24/1997
Decision Date 04/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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