510(k) K023489

QUICKTOX MULTIPLE DRUG DIPCARD by Branan Medical Corp. — Product Code DIO

K023489 is an FDA 510(k) premarket notification submitted by Branan Medical Corp. for the device "QUICKTOX MULTIPLE DRUG DIPCARD". The FDA issued a decision of Substantially Equivalent on December 16, 2002. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Branan Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2002
Date Received
October 17, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type