510(k) K103612
K103612 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "DIMENSION VISA ENZ 2 CAL". The FDA issued a decision of Substantially Equivalent on January 25, 2011. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2011
- Date Received
- December 9, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Multi-Analyte Mixture
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type