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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
Recalls CDRH Recalls
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