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FDA 510(k)

MODIFICATION TO AESKULISA DS DNA G

K-Number: K081251 · 2008-05-13

ApplicantAesku Diagnostics
Decision Date2008-05-13
Product CodeLSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO AESKULISA DS DNA G is the device name listed in this FDA 510(k) record. The listed applicant is Aesku Diagnostics. It received FDA 510(k) clearance on 2008-05-13 under 510(k) number K081251. The device is classified under product code LSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO AESKULISA DS DNA G?

MODIFICATION TO AESKULISA DS DNA G is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is Aesku Diagnostics. The 510(k) number is K081251.

When did MODIFICATION TO AESKULISA DS DNA G receive FDA 510(k) clearance?

MODIFICATION TO AESKULISA DS DNA G received FDA 510(k) clearance on 2008-05-13, under 510(k) number K081251.

Who is the listed applicant for MODIFICATION TO AESKULISA DS DNA G?

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 MODIFICATION TO AESKULISA DS DNA G?

The FDA product code for MODIFICATION TO AESKULISA DS DNA G is LSW.

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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.

K132082AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECKK120889AESKUSLIDES ANA HEP-2K091859AESKU PR3K091860AESKULISA MPO, MODEL 30-7303USK081104AESKULISA ANA HEP-2, REF 30-7115USK052439AESKULISA GLIA A AND AESKULISA GLIA G

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Related Devices (Code: LSW)

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.

K172348AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10Aesku.Diagnostics GmbH & Co. KGK152013QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsInova Diagnostics, Inc.K072393ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01Phadia US, Inc.K060380FIDIS DSDNABiomedical Diagnostics (Bmd) SAK041628AESKULISA DS DNA GAesku DiagnosticsK921658ANTI-DSDNA ANTIBODY TESTImmco 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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