510(k) K152245
K152245 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "ONLINE TDM Vancomycin Gen.3". The FDA issued a decision of Substantially Equivalent on January 8, 2016. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 2016
- Date Received
- August 10, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Vancomycin
- Device Class
- Class II
- Regulation Number
- 862.3950
- Review Panel
- TX
- Submission Type