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FDA 510(k)

VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896

K-Number: K041354 · 2004-07-16

ApplicantSweden Diagnostics (Germany) GmbH
Decision Date2004-07-16
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 is the device name listed in this FDA 510(k) record. The listed applicant is Sweden Diagnostics (Germany) GmbH. It received FDA 510(k) clearance on 2004-07-16 under 510(k) number K041354. 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 VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896?

VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 is a medical device that received FDA 510(k) clearance on 2004-07-16. The listed applicant is Sweden Diagnostics (Germany) GmbH. The 510(k) number is K041354.

When did VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 receive FDA 510(k) clearance?

VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 received FDA 510(k) clearance on 2004-07-16, under 510(k) number K041354.

Who is the listed applicant for VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896?

The FDA 510(k) record lists Sweden Diagnostics (Germany) GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896?

The FDA product code for VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 is MST.

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Other records listing Sweden Diagnostics (Germany) GmbH 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.

K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096K050625VARELISA RECOMBI ANA PROFILE, MODEL 18496K042629VARELISA SM ANTIBODIES, MODEL 18296K041357VARELISA GLIADIN IGG ANTIBODIESK041173CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996K041174CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196

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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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