510(k) K023712
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