510(k) K023712

ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST by Advantage Diagnostics Corp. — Product Code DKZ

K023712 is an FDA 510(k) premarket notification submitted by Advantage Diagnostics Corp. for the device "ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST". The FDA issued a decision of Substantially Equivalent on January 31, 2003. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Advantage Diagnostics Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2003
Date Received
November 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type