510(k) K781048

THC DIRECT RIA KIT by Immunalysis Corporation — Product Code LAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1978
Date Received
June 21, 1978
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