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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioassay, vitamin b12
510(k) Number K121314
Device Name ARCHITECT B12
Original Applicant
100 abbott park road
dept. 09v6 ap5 north
abbott park,  IL  60064
Original Contact darla a abano
Regulation Number862.1810
Classification Product Code
Subsequent Product Codes
Date Received05/02/2012
Decision Date 05/17/2012
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