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FDA 510(k)

FIDIS CELIAC

K-Number: K053383 · 2006-03-29

ApplicantBiomedical Diagnostics (Bmd) SA
Decision Date2006-03-29
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIDIS CELIAC 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 2006-03-29 under 510(k) number K053383. The device is classified under product code MST. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIDIS CELIAC?

FIDIS CELIAC is a medical device that received FDA 510(k) clearance on 2006-03-29. The listed applicant is Biomedical Diagnostics (Bmd) SA. The 510(k) number is K053383.

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

FIDIS CELIAC received FDA 510(k) clearance on 2006-03-29, under 510(k) number K053383.

Who is the listed applicant for FIDIS CELIAC?

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 CELIAC?

The FDA product code for FIDIS CELIAC is MST.

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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: MST)

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.

K163177ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAImmco Diagnostics, Inc.K132082AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECKAesku DiagnosticsK113377GLIADIN IGA AND GLIADIN LGAGrifols USA, LLCK113863QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORSInova Diagnostics, Inc.K111414QUANTA FLASH (TM) DGP SCREENInova Diagnostics, Inc.K093459ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01Phadia US, 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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