510(k) K002263

BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST by Branan Medical Corp. — Product Code LDJ

K002263 is an FDA 510(k) premarket notification submitted by Branan Medical Corp. for the device "BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST". The FDA issued a decision of Substantially Equivalent on November 27, 2000. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Branan Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2000
Date Received
July 25, 2000
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