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FDA 510(k)

Aptiva Celiac Disease IgG Reagent

K-Number: K200230 · 2021-08-26

ApplicantInova Diagnostics, Inc.
Decision Date2021-08-26
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Aptiva Celiac Disease IgG Reagent 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 2021-08-26 under 510(k) number K200230. 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 Aptiva Celiac Disease IgG Reagent?

Aptiva Celiac Disease IgG Reagent is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K200230.

When did Aptiva Celiac Disease IgG Reagent receive FDA 510(k) clearance?

Aptiva Celiac Disease IgG Reagent received FDA 510(k) clearance on 2021-08-26, under 510(k) number K200230.

Who is the listed applicant for Aptiva Celiac Disease IgG Reagent?

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 Aptiva Celiac Disease IgG Reagent?

The FDA product code for Aptiva Celiac Disease IgG Reagent is MVM.

Other records listing Inova Diagnostics, Inc. 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.

K243979Aptiva APS IgA ReagentK223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentK213403Aptiva CTD Essential ReagentK193604Aptiva Celiac Disease IgA ReagentK192916NOVA Lite DAPI dsDNA Crithidia luciliae KitK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

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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.

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.

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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