ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS— 510(k) K013152
Substantially EquivalentElan Holdings, Inc.
FDA 510(k) clearance K013152 for ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS, Substantially Equivalent on 2001-11-09. Applicant: Elan Holdings, Inc..
Clearance details
- Applicant
- Elan Holdings, Inc.
- Product code
- Code LBS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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