ARCHITECT CA 125 II ASSAY— 510(k) K042731
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K042731 for ARCHITECT CA 125 II ASSAY, Substantially Equivalent on 2004-11-19. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code LTK
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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