CRP-LATEX (II)X2 SEIKEN ASSAY KIT— 510(k) K030545
Substantially EquivalentDenka Seiken Co., Ltd.
FDA 510(k) clearance K030545 for CRP-LATEX (II)X2 SEIKEN ASSAY KIT, Substantially Equivalent on 2003-06-02. Applicant: Denka Seiken Co., Ltd..
Clearance details
- Applicant
- Denka Seiken Co., Ltd.
- Product code
- Code DCK
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gosen City, Niigata, JP
Data sourced from openFDA. This site is unofficial and independent of the FDA.