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510(k) K043071

RANDOX PHENCYCLIDINE ASSAY by Randox Laboratories, Ltd. — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2005
Date Received
November 8, 2004
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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