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FDA 510(k)

ELIA GLIADIN IGA, IGG AND CELIAC CONTROL

K-Number: K063775 · 2007-03-14

ApplicantPhadia US, Inc.
Decision Date2007-03-14
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELIA GLIADIN IGA, IGG AND CELIAC CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Phadia US, Inc.. It received FDA 510(k) clearance on 2007-03-14 under 510(k) number K063775. 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 ELIA GLIADIN IGA, IGG AND CELIAC CONTROL?

ELIA GLIADIN IGA, IGG AND CELIAC CONTROL is a medical device that received FDA 510(k) clearance on 2007-03-14. The listed applicant is Phadia US, Inc.. The 510(k) number is K063775.

When did ELIA GLIADIN IGA, IGG AND CELIAC CONTROL receive FDA 510(k) clearance?

ELIA GLIADIN IGA, IGG AND CELIAC CONTROL received FDA 510(k) clearance on 2007-03-14, under 510(k) number K063775.

Who is the listed applicant for ELIA GLIADIN IGA, IGG AND CELIAC CONTROL?

The FDA 510(k) record lists Phadia US, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELIA GLIADIN IGA, IGG AND CELIAC CONTROL?

The FDA product code for ELIA GLIADIN IGA, IGG AND CELIAC CONTROL is MST.

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Other records listing Phadia US, Inc. 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.

K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYK122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESK113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLEK112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYK111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSK102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

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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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