FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM— 510(k) K100917
Substantially EquivalentBiomedical Diagnostics (Bmd) SA
FDA 510(k) clearance K100917 for FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM, Substantially Equivalent on 2010-11-03. Applicant: Biomedical Diagnostics (Bmd) SA. Device class: 2.
Clearance details
- Applicant
- Biomedical Diagnostics (Bmd) SA
- Product code
- Code MOB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marne La Vallee Cedex 2, FR
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- K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
More clearances from Biomedical Diagnostics (Bmd) SA
view allData sourced from openFDA. This site is unofficial and independent of the FDA.