510(k) K990409
K990409 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)". The FDA issued a decision of Substantially Equivalent on April 15, 1999. The device falls under product code DMY (Gas Chromatography, Morphine), a Class II device regulated under 21 CFR 862.3640. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 1999
- Date Received
- February 9, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas Chromatography, Morphine
- Device Class
- Class II
- Regulation Number
- 862.3640
- Review Panel
- TX
- Submission Type