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FDA 510(k)

FIDIS DSDNA

K-Number: K060380 · 2006-05-02

ApplicantBiomedical Diagnostics (Bmd) SA
Decision Date2006-05-02
Product CodeLSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIDIS DSDNA is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Diagnostics (Bmd) SA. It received FDA 510(k) clearance on 2006-05-02 under 510(k) number K060380. The device is classified under product code LSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIDIS DSDNA?

FIDIS DSDNA is a medical device that received FDA 510(k) clearance on 2006-05-02. The listed applicant is Biomedical Diagnostics (Bmd) SA. The 510(k) number is K060380.

When did FIDIS DSDNA receive FDA 510(k) clearance?

FIDIS DSDNA received FDA 510(k) clearance on 2006-05-02, under 510(k) number K060380.

Who is the listed applicant for FIDIS DSDNA?

The FDA 510(k) record lists Biomedical Diagnostics (Bmd) SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIDIS DSDNA?

The FDA product code for FIDIS DSDNA is LSW.

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Other records listing Biomedical Diagnostics (Bmd) SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102607FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARISK100917FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEMK070458MODIFICATION TO FIDIS VASCULITIS, MODEL MX007K071210MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006K061794FIDIS TM THYRO, MODEL MX002K053383FIDIS CELIAC

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Related Devices (Code: LSW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172348AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10Aesku.Diagnostics GmbH & Co. KGK152013QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsInova Diagnostics, Inc.K081251MODIFICATION TO AESKULISA DS DNA GAesku DiagnosticsK072393ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01Phadia US, Inc.K041628AESKULISA DS DNA GAesku DiagnosticsK921658ANTI-DSDNA ANTIBODY TESTImmco Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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