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FDA 510(k)

AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK

K-Number: K132082 · 2013-12-05

ApplicantAesku Diagnostics
Decision Date2013-12-05
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Aesku Diagnostics. It received FDA 510(k) clearance on 2013-12-05 under 510(k) number K132082. 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 AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK?

AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK is a medical device that received FDA 510(k) clearance on 2013-12-05. The listed applicant is Aesku Diagnostics. The 510(k) number is K132082.

When did AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK receive FDA 510(k) clearance?

AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK received FDA 510(k) clearance on 2013-12-05, under 510(k) number K132082.

Who is the listed applicant for AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK?

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

What is the FDA product code for AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK?

The FDA product code for AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK is MST.

Related Clinical Trials

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Other records listing Aesku Diagnostics 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.

K120889AESKUSLIDES ANA HEP-2K091859AESKU PR3K091860AESKULISA MPO, MODEL 30-7303USK081251MODIFICATION TO AESKULISA DS DNA GK081104AESKULISA ANA HEP-2, REF 30-7115USK052439AESKULISA GLIA A AND AESKULISA GLIA G

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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.K113377GLIADIN 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.K111414QUANTA FLASH (TM) DGP SCREENInova 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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