K991789
Substantially EquivalentATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
- Applicant
- Elan Holdings, Inc.
- Product 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.