510(k) K093884
K093884 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ROCHE FLUDI METHAMPHETAMINE". The FDA issued a decision of Substantially Equivalent on February 25, 2011. The device falls under product code LAF (Gas Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 2011
- Date Received
- December 18, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas Chromatography, Methamphetamine
- Device Class
- Class II
- Regulation Number
- 862.3610
- Review Panel
- TX
- Submission Type