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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, vancomycin
510(k) Number K072036
Device Name ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
Applicant
BIOKIT S.A.
CAN MALE S/N
LLICA D'AMUNT
barcelona,  ES 08186
Applicant Contact joan guixer
Correspondent
BIOKIT S.A.
CAN MALE S/N
LLICA D'AMUNT
barcelona,  ES 08186
Correspondent Contact joan guixer
Regulation Number862.3950
Classification Product Code
LEH  
Subsequent Product Code
DLJ  
Date Received07/25/2007
Decision Date 03/19/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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