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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 K132400
Device Name LP(A) CALIBRATORS, AND LP(A) CONTROLS
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 Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJX  
Date Received08/01/2013
Decision Date 12/19/2013
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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