510(k) K910892

TARGET(TM) CANNABINOIDS-V TEST by V-Tech, Inc. — Product Code LDJ

K910892 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "TARGET(TM) CANNABINOIDS-V TEST". The FDA issued a decision of Substantially Equivalent on April 3, 1991. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. V-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1991
Date Received
March 4, 1991
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