510(k) K123947
K123947 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT IVANCOMYCIN". The FDA issued a decision of Substantially Equivalent on August 29, 2013. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. Biokit, S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2013
- Date Received
- December 21, 2012
- 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