510(k) K022501
K022501 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST". The FDA issued a decision of Substantially Equivalent on November 13, 2002. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Alfa Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2002
- Date Received
- July 29, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thin Layer Chromatography, Methamphetamine
- Device Class
- Class II
- Regulation Number
- 862.3610
- Review Panel
- TX
- Submission Type