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FDA 510(k)

DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM

K-Number: K012797 · 2001-09-28

ApplicantDiamedix Corp.
Decision Date2001-09-28
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 2001-09-28 under 510(k) number K012797. 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 DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM?

DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is Diamedix Corp.. The 510(k) number is K012797.

When did DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM receive FDA 510(k) clearance?

DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM received FDA 510(k) clearance on 2001-09-28, under 510(k) number K012797.

Who is the listed applicant for DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM?

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

What is the FDA product code for DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM?

The FDA product code for DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM is MST.

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Other records listing Diamedix Corp. 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.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM 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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