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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Carbamazepine
510(k) Number K955644
Device Name SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea,  CA  92622 -8000
Applicant Contact SHERI HALL
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea,  CA  92622 -8000
Correspondent Contact SHERI HALL
Regulation Number862.3645
Classification Product Code
KLT  
Subsequent Product Codes
DIP   DKB   KLS   LCD   LCQ  
LCR   LFN  
Date Received12/12/1995
Decision Date 02/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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