RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY— 510(k) K001032
Substantially EquivalentOtsuka Pharmaceutical Co., Ltd.
FDA 510(k) clearance K001032 for RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY, Substantially Equivalent on 2000-07-24. Applicant: Otsuka Pharmaceutical Co., Ltd..
Clearance details
- Applicant
- Otsuka Pharmaceutical Co., Ltd.
- Product code
- Code CHH
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.