510(k) K043305
K043305 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ONLINE DAT PHENCYCLIDINE PLUS". The FDA issued a decision of Substantially Equivalent on January 10, 2005. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 2005
- Date Received
- November 30, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Phencyclidine
- Device Class
- Class U
- Regulation Number
- Review Panel
- TX
- Submission Type