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FDA 510(k)

QUANTA FLASH (TM) DGP SCREEN

K-Number: K111414 · 2011-10-20

ApplicantInova Diagnostics, Inc.
Decision Date2011-10-20
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA FLASH (TM) DGP SCREEN 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 2011-10-20 under 510(k) number K111414. 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 QUANTA FLASH (TM) DGP SCREEN?

QUANTA FLASH (TM) DGP SCREEN is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K111414.

When did QUANTA FLASH (TM) DGP SCREEN receive FDA 510(k) clearance?

QUANTA FLASH (TM) DGP SCREEN received FDA 510(k) clearance on 2011-10-20, under 510(k) number K111414.

Who is the listed applicant for QUANTA FLASH (TM) DGP SCREEN?

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 (TM) DGP SCREEN?

The FDA product code for QUANTA FLASH (TM) DGP SCREEN is MST.

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Other records listing Inova Diagnostics, Inc. as applicant

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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.K093459ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01Phadia US, Inc.K091522IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISAImmco Diagnostics, 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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