510(k) K904635

MICROZYME THC ENZYME IMMUNOASSAY TEST KIT by Immunotech Corp. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1990
Date Received
October 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type