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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrators, drug mixture
510(k) Number K981403
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-104
BREA,  CA  92621
Applicant Contact ANNETTE HELLIE
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-104
BREA,  CA  92621
Correspondent Contact ANNETTE HELLIE
Regulation Number862.3200
Classification Product Code
DKB  
Date Received04/17/1998
Decision Date 05/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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