ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS— 510(k) K992029
Substantially EquivalentElan Diagnostics
FDA 510(k) clearance K992029 for ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS, Substantially Equivalent on 1999-08-12. Applicant: Elan Diagnostics. Device class: 1.
Clearance details
- Applicant
- Elan 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
- Brea, CA, US
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More clearances from Elan Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.