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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, folic, radioimmunoassay
510(k) Number K092740
Device Name ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK ROAD
DEPT. 9V6 AP6C-2
ABBOTT PARK,  IL  60064
Applicant Contact DARLA ABANO
Correspondent
ABBOTT LABORATORIES
100 ABBOTT PARK ROAD
DEPT. 9V6 AP6C-2
ABBOTT PARK,  IL  60064
Correspondent Contact DARLA ABANO
Regulation Number862.1295
Classification Product Code
CGN  
Subsequent Product Codes
JIT   JJX  
Date Received09/08/2009
Decision Date 03/05/2010
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
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