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FDA 510(k)

FIDIS VASCULITIS, MODEL MX007

K-Number: K053012 · 2006-03-02

ApplicantBiomedical Diagnostics (Bmd) SA
Decision Date2006-03-02
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIDIS VASCULITIS, MODEL MX007 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 2006-03-02 under 510(k) number K053012. 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, MODEL MX007?

FIDIS VASCULITIS, MODEL MX007 is a medical device that received FDA 510(k) clearance on 2006-03-02. The listed applicant is Biomedical Diagnostics (Bmd) SA. The 510(k) number is K053012.

When did FIDIS VASCULITIS, MODEL MX007 receive FDA 510(k) clearance?

FIDIS VASCULITIS, MODEL MX007 received FDA 510(k) clearance on 2006-03-02, under 510(k) number K053012.

Who is the listed applicant for FIDIS VASCULITIS, MODEL MX007?

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, MODEL MX007?

The FDA product code for FIDIS VASCULITIS, MODEL MX007 is MOB.

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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 MX002K060380FIDIS DSDNA

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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.

K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMZeus ScientificK243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus ScientificK172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KGK173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia ABK161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova 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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