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510(k) K152176

Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators by Immunalysis Corporation — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2015
Date Received
August 4, 2015
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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