Home / 510(k) Clearances / K121608

510(k) K121608

VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS by Ortho-Clinical Diagnostics, Inc. — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2013
Date Received
June 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Vitamin D
Device Class
Class II
Regulation Number
862.1825
Review Panel
CH
Submission Type

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