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510(k) K913864

PCP DIRECT RIA KIT (I-125) by Immunalysis Corporation — Product Code LCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1991
Date Received
August 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Phencyclidine
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

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