ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS— 510(k) K991789
Substantially EquivalentElan Holdings, Inc.
FDA 510(k) clearance K991789 for ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS, Substantially Equivalent on 1999-07-09. Applicant: Elan Holdings, Inc..
Clearance details
- Applicant
- Elan Holdings, Inc.
- Product code
- Code LBR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.