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FDA 510(k)

EU-TTG IGA ELISA

K-Number: K994379 · 2000-02-18

ApplicantScimedx Corp.
Decision Date2000-02-18
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EU-TTG IGA ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Scimedx Corp.. It received FDA 510(k) clearance on 2000-02-18 under 510(k) number K994379. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EU-TTG IGA ELISA?

EU-TTG IGA ELISA is a medical device that received FDA 510(k) clearance on 2000-02-18. The listed applicant is Scimedx Corp.. The 510(k) number is K994379.

When did EU-TTG IGA ELISA receive FDA 510(k) clearance?

EU-TTG IGA ELISA received FDA 510(k) clearance on 2000-02-18, under 510(k) number K994379.

Who is the listed applicant for EU-TTG IGA ELISA?

The FDA 510(k) record lists Scimedx Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EU-TTG IGA ELISA?

The FDA product code for EU-TTG IGA ELISA is MVM.

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Other records listing Scimedx Corp. as applicant

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Related Devices (Code: MVM)

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.

K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc.K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc.K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayPhadia ABK183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)Euroimmun Us, Inc.K123713IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISAImmco Diagnostics, Inc.K130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIBio-Rad Laboratories, 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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