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FDA 510(k)

QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA

K-Number: K011566 · 2001-07-09

ApplicantInova Diagnostics, Inc.
Decision Date2001-07-09
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-07-09 under 510(k) number K011566. 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 QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA?

QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA is a medical device that received FDA 510(k) clearance on 2001-07-09. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K011566.

When did QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA receive FDA 510(k) clearance?

QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA received FDA 510(k) clearance on 2001-07-09, under 510(k) number K011566.

Who is the listed applicant for QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA?

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

What is the FDA product code for QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA?

The FDA product code for QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA is MVM.

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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

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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