DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR— 510(k) K050823
Substantially EquivalentTeco Diagnostics
FDA 510(k) clearance K050823 for DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR, Substantially Equivalent on 2005-07-26. Applicant: Teco Diagnostics. Device class: 1.
Clearance details
- Applicant
- Teco Diagnostics
- Product code
- Code LBR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
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More clearances from Teco Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.