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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 K963673
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622 -8000
Applicant Contact ANNETTE HELLIE
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622 -8000
Correspondent Contact ANNETTE HELLIE
Regulation Number862.3645
Classification Product Code
KLT  
Subsequent Product Codes
DKB   LGQ   LGR   LGS  
Date Received09/13/1996
Decision Date 02/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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