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510(k) K023875

VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 by Ortho-Clinical Diagnostics, Inc. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2002
Date Received
November 21, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

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