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510(k) K983690

VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK by Ortho-Clinical Diagnostics, Inc. — Product Code MOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1999
Date Received
October 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Immunological, Antigen, Tumor
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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