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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, vitamin d
510(k) Number K153375
Device Name ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
Applicant
ABBOTT LABORATORIES
DEPT 093E, BLDG. AP 8
100 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6038
Applicant Contact LAURA YELVIGI JOGLEKAR
Correspondent
ABBOTT LABORATORIES
DEPT 09AA, BLDG. AP8-1
100 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6038
Correspondent Contact JUDITH R WALLACH
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JIT   JJX  
Date Received11/23/2015
Decision Date 08/12/2016
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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