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510(k) K062094

VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V by Ortho-Clinical Diagnostics, Inc. — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2006
Date Received
July 24, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phencyclidine
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

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