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FDA 510(k)

IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA

K-Number: K091520 · 2010-03-10

ApplicantImmco Diagnostics, Inc.
Decision Date2010-03-10
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2010-03-10 under 510(k) number K091520. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA?

IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA is a medical device that received FDA 510(k) clearance on 2010-03-10. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K091520.

When did IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA receive FDA 510(k) clearance?

IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA received FDA 510(k) clearance on 2010-03-10, under 510(k) number K091520.

Who is the listed applicant for IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA?

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

What is the FDA product code for IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA?

The FDA product code for IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA is MVM.

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Other records listing Immco Diagnostics, Inc. as applicant

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Related Devices (Code: MVM)

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.

K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc.K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc.K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayPhadia ABK183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)Euroimmun Us, Inc.K123713IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISAImmco Diagnostics, Inc.K130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIBio-Rad Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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