510(k) K033902
K033902 is an FDA 510(k) premarket notification submitted by Varian, Inc. for the device "ONTRAK TESTCUP II AND ONSITE CUPKIT". The FDA issued a decision of Substantially Equivalent on January 20, 2004. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Varian, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 2004
- Date Received
- December 17, 2003
- Clearance Type
- Special
- 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