510(k) K010030
K010030 is an FDA 510(k) premarket notification submitted by Synergent Biochem Inc.-Clinical Controls Div. for the device "LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR". The FDA issued a decision of Substantially Equivalent on Feb 14, 2001. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 14, 2001
- Date Received
- Jan 3, 2001
- 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
- 510(k) Exempt