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FDA 510(k)

GLIADIN ANTIBODIES ELISA

K-Number: K973910 · 1999-02-17

ApplicantGenesis Diagnostics , Ltd.
Decision Date1999-02-17
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GLIADIN ANTIBODIES ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Diagnostics , Ltd.. It received FDA 510(k) clearance on 1999-02-17 under 510(k) number K973910. 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 ANTIBODIES ELISA?

GLIADIN ANTIBODIES ELISA is a medical device that received FDA 510(k) clearance on 1999-02-17. The listed applicant is Genesis Diagnostics , Ltd.. The 510(k) number is K973910.

When did GLIADIN ANTIBODIES ELISA receive FDA 510(k) clearance?

GLIADIN ANTIBODIES ELISA received FDA 510(k) clearance on 1999-02-17, under 510(k) number K973910.

Who is the listed applicant for GLIADIN ANTIBODIES ELISA?

The FDA 510(k) record lists Genesis Diagnostics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLIADIN ANTIBODIES ELISA?

The FDA product code for GLIADIN ANTIBODIES ELISA is MST.

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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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