510(k) K060586
K060586 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ENZYME IMMUNOASSAY, VANCOMYCIN". The FDA issued a decision of Substantially Equivalent on May 11, 2006. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2006
- Date Received
- March 7, 2006
- 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