FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20— 510(k) K101809
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K101809 for FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20, Substantially Equivalent on 2010-10-05. Applicant: Fujirebio Diagnostics,Inc.. Device class: 1.
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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