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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 K110579
Device Name ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Dept 9v6, Ap5n-2
Abbott Park,  IL  60064
Applicant Contact DARLA ABANO
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Dept 9v6, Ap5n-2
Abbott Park,  IL  60064
Correspondent Contact DARLA ABANO
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Codes
JIT   JJX  
Date Received03/01/2011
Decision Date 10/06/2011
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
Predetermined Change
Control Plan Authorized		 No
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