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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, parathyroid hormone
510(k) Number K063232
Device Name ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
Applicant
BIOKIT S.A.
CAN MALE LLISSA D'AMUNT
BARCELONA,  ES 08186
Applicant Contact JOAN GUIXER
Correspondent
BIOKIT S.A.
CAN MALE LLISSA D'AMUNT
BARCELONA,  ES 08186
Correspondent Contact JOAN GUIXER
Regulation Number862.1545
Classification Product Code
CEW  
Subsequent Product Codes
JIT   JJX  
Date Received10/25/2006
Decision Date 06/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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