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510(k) K042494

VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III by Ortho-Clinical Diagnostics — Product Code CZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2004
Date Received
September 14, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C3, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

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