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510(k) K181135

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2019
Date Received
April 30, 2018
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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