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FDA 510(k)

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

K-Number: K100917 · 2010-11-03

ApplicantBiomedical Diagnostics (Bmd) SA
Decision Date2010-11-03
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM 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 2010-11-03 under 510(k) number K100917. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM?

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-03. The listed applicant is Biomedical Diagnostics (Bmd) SA. The 510(k) number is K100917.

When did FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM receive FDA 510(k) clearance?

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM received FDA 510(k) clearance on 2010-11-03, under 510(k) number K100917.

Who is the listed applicant for FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM?

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 VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM?

The FDA product code for FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM is MOB.

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Other records listing Biomedical Diagnostics (Bmd) SA as applicant

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Related Devices (Code: MOB)

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.

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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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