510(k) K983188

DBEST TETRAHYDROCANNABINOL TEST KIT by Ameritek, Inc. — Product Code LDJ

K983188 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "DBEST TETRAHYDROCANNABINOL TEST KIT". The FDA issued a decision of Substantially Equivalent on November 18, 1998. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Ameritek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1998
Date Received
September 11, 1998
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