510(k) K081533
K081533 is an FDA 510(k) premarket notification submitted by SENTINEL CH. SpA for the device "SENTINEL PLASMAPROTEINS CAL 3X". The FDA issued a decision of Substantially Equivalent on June 25, 2008. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. SENTINEL CH. SpA has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2008
- Date Received
- June 2, 2008
- 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