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510(k) K043305

ONLINE DAT PHENCYCLIDINE PLUS by Roche Diagnostics Corp. — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2005
Date Received
November 30, 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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  • K131181 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE (June 25, 2013)
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  • K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA (May 1, 2012)
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