510(k) K122398
K122398 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS". The FDA issued a decision of Substantially Equivalent on October 12, 2012. 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
- October 12, 2012
- Date Received
- August 7, 2012
- 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