510(k) K043211
K043211 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ONLINE DAT BARBITURATES PLUS". The FDA issued a decision of Substantially Equivalent on December 29, 2004. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2004
- Date Received
- November 19, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Barbiturate
- Device Class
- Class II
- Regulation Number
- 862.3150
- Review Panel
- TX
- Submission Type