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510(k) K913865

URINE THC DIRECT RIA KIT (I-125) by Immunalysis Corporation — Product Code LAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1991
Date Received
August 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cannabinoid(S)
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

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