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FDA 510(k)

FIDIS CELIAC

K-Number: K041002 · 2004-09-24

ApplicantBiomedical Diagnostics S.A.
Decision Date2004-09-24
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 S.A.. It received FDA 510(k) clearance on 2004-09-24 under 510(k) number K041002. 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 2004-09-24. The listed applicant is Biomedical Diagnostics S.A.. The 510(k) number is K041002.

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

FIDIS CELIAC received FDA 510(k) clearance on 2004-09-24, under 510(k) number K041002.

Who is the listed applicant for FIDIS CELIAC?

The FDA 510(k) record lists Biomedical Diagnostics S.A. 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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Official Source

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

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