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510(k) K042643

VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II by Ortho-Clinical Diagnostics, Inc. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2004
Date Received
September 27, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
Submission Type

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