510(k) K151578
K151578 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "Carbamazepine Gen 4". The FDA issued a decision of Substantially Equivalent on October 22, 2015. The device falls under product code KLT (Enzyme Immunoassay, Carbamazepine), a Class II device regulated under 21 CFR 862.3645. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2015
- Date Received
- June 11, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Carbamazepine
- Device Class
- Class II
- Regulation Number
- 862.3645
- Review Panel
- TX
- Submission Type