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FDA 510(k)

GLIADIN IGA AND GLIADIN LGA

K-Number: K113377 · 2012-12-14

ApplicantGrifols USA, LLC
Decision Date2012-12-14
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GLIADIN IGA AND GLIADIN LGA is the device name listed in this FDA 510(k) record. The listed applicant is Grifols USA, LLC. It received FDA 510(k) clearance on 2012-12-14 under 510(k) number K113377. 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 GLIADIN IGA AND GLIADIN LGA?

GLIADIN IGA AND GLIADIN LGA is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is Grifols USA, LLC. The 510(k) number is K113377.

When did GLIADIN IGA AND GLIADIN LGA receive FDA 510(k) clearance?

GLIADIN IGA AND GLIADIN LGA received FDA 510(k) clearance on 2012-12-14, under 510(k) number K113377.

Who is the listed applicant for GLIADIN IGA AND GLIADIN LGA?

The FDA 510(k) record lists Grifols USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLIADIN IGA AND GLIADIN LGA?

The FDA product code for GLIADIN IGA AND GLIADIN LGA is MST.

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Other records listing Grifols USA, LLC 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.

K120169INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT

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 DiagnosticsK113863QUANTA 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.K091522IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISAImmco 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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