LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR— 510(k) K010030
Substantially EquivalentSynergent Biochem Inc.-Clinical Controls Div.
FDA 510(k) clearance K010030 for LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR, Substantially Equivalent on 2001-02-14. Applicant: Synergent Biochem Inc.-Clinical Controls Div.. Device class: 2.
Clearance details
- Applicant
- Synergent Biochem Inc.-Clinical Controls Div.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hawaiian Gardens, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.