ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS— 510(k) K020575
Substantially EquivalentElan Diagnostics
FDA 510(k) clearance K020575 for ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS, Substantially Equivalent on 2002-04-12. Applicant: Elan Diagnostics. Device class: 1.
Clearance details
- Applicant
- Elan Diagnostics
- Product code
- Code MRR
- 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
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