510(k) K011609
K011609 is an FDA 510(k) premarket notification submitted by Pan Probe Biotech, Inc. for the device "LIVESURE AMPHETAMINE SCREEN TEST". The FDA issued a decision of Substantially Equivalent on June 8, 2001. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Pan Probe Biotech, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2001
- Date Received
- May 25, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Enzyme Immunoassay, Amphetamine
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type