510(k) K071644
K071644 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620". The FDA issued a decision of Substantially Equivalent on September 12, 2007. The device falls under product code DLZ (Enzyme Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2007
- Date Received
- June 15, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Phenobarbital
- Device Class
- Class II
- Regulation Number
- 862.3660
- Review Panel
- TX
- Submission Type