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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 K180577
Device Name BioPlex 2200 25-OH Vitamin D Kit
Applicant
Bio-Rad Laboratories
5500 E. Second St.
Benicia,  CA  94510
Applicant Contact Arlene Carillo
Correspondent
Bio-Rad Laboratories
5500 E. Second St.
Benicia,  CA  94510
Correspondent Contact Arlene Carillo
Regulation Number862.1825
Classification Product Code
MRG  
Date Received03/05/2018
Decision Date 06/22/2018
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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