510(k) K043327
K043327 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ONLINE DAT BENZODIAZEPINES PLUS". The FDA issued a decision of Substantially Equivalent on February 7, 2005. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2005
- Date Received
- December 2, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Benzodiazepine
- Device Class
- Class II
- Regulation Number
- 862.3170
- Review Panel
- TX
- Submission Type