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510(k) K203489

SEFRIA PCP Oral Fluid Enzyme Immunoassay by Immunalysis Corporation — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2021
Date Received
November 27, 2020
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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Other clearances for product code LCM

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  • K122703 — RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAP (April 25, 2013)
  • K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA (May 1, 2012)
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