510(k) K872882

CANNABINOID ENZYME IMMUNOASSAY KIT by General Diagnostics — Product Code LDJ

K872882 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "CANNABINOID ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on November 3, 1987. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. General Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1987
Date Received
July 22, 1987
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