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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K082141
Device Name ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10
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 Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJX  
Date Received07/30/2008
Decision Date 09/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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