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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescence Polarization Immunoassay, Theophylline
510(k) Number K070810
Device Name ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
Applicant
Biokit, S.A.
Can Male S/N
Llissa D'Amunt
Barcelona,  ES 08186
Applicant Contact JOAN GUIXER
Correspondent
Biokit, S.A.
Can Male S/N
Llissa D'Amunt
Barcelona,  ES 08186
Correspondent Contact JOAN GUIXER
Regulation Number862.3880
Classification Product Code
LGS  
Subsequent Product Code
DLJ  
Date Received03/26/2007
Decision Date 06/08/2007
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
Predetermined Change
Control Plan Authorized		 No
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