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510(k) K042477

VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN by Ortho-Clinical Diagnostics, Inc. — Product Code DDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2004
Date Received
September 13, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transferrin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
Submission Type

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