510(k) K062521
K062521 is an FDA 510(k) premarket notification submitted by Thermo-Electron Corp. for the device "OXALATE URINE CONTROLS (NORMAL AND ELEVATED)". The FDA issued a decision of Substantially Equivalent on March 16, 2007. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Thermo-Electron Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2007
- Date Received
- August 28, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Secondary
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type