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FDA 510(k)

AESKULISA DS DNA G

K-Number: K041628 · 2004-10-14

ApplicantAesku Diagnostics
Decision Date2004-10-14
Product CodeLSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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 2004-10-14 under 510(k) number K041628. 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 AESKULISA DS DNA G?

AESKULISA DS DNA G is a medical device that received FDA 510(k) clearance on 2004-10-14. The listed applicant is Aesku Diagnostics. The 510(k) number is K041628.

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

AESKULISA DS DNA G received FDA 510(k) clearance on 2004-10-14, under 510(k) number K041628.

Who is the listed applicant for 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 AESKULISA DS DNA G?

The FDA product code for 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 30-7303USK081251MODIFICATION TO AESKULISA DS DNA GK081104AESKULISA ANA HEP-2, REF 30-7115US

View all 9 devices →

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.K081251MODIFICATION TO AESKULISA DS DNA GAesku DiagnosticsK072393ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01Phadia US, Inc.K060380FIDIS DSDNABiomedical Diagnostics (Bmd) SAK921658ANTI-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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