FIDIS DSDNA— 510(k) K060380
Substantially EquivalentBiomedical Diagnostics (Bmd) SA
FDA 510(k) clearance K060380 for FIDIS DSDNA, Substantially Equivalent on 2006-05-02. Applicant: Biomedical Diagnostics (Bmd) SA. Device class: 2.
Clearance details
- Applicant
- Biomedical Diagnostics (Bmd) SA
- Product code
- Code LSW
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marne La Vallee Cedex 2, FR
Recent devices under product code LSW
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- K081251 — MODIFICATION TO AESKULISA DS DNA G
- K072393 — ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
- K041628 — AESKULISA DS DNA G
More clearances from Biomedical Diagnostics (Bmd) SA
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