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FDA 510(k)

QUANTA FLASH H-TTG IGA

K-Number: K094060 · 2010-10-13

ApplicantInova Diagnostics, Inc.
Decision Date2010-10-13
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA FLASH H-TTG IGA 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 2010-10-13 under 510(k) number K094060. 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 FLASH H-TTG IGA?

QUANTA FLASH H-TTG IGA is a medical device that received FDA 510(k) clearance on 2010-10-13. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K094060.

When did QUANTA FLASH H-TTG IGA receive FDA 510(k) clearance?

QUANTA FLASH H-TTG IGA received FDA 510(k) clearance on 2010-10-13, under 510(k) number K094060.

Who is the listed applicant for QUANTA FLASH H-TTG IGA?

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 FLASH H-TTG IGA?

The FDA product code for QUANTA FLASH H-TTG IGA 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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