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FDA 510(k)

AESKULISA ANA HEP-2, REF 30-7115US

K-Number: K081104 · 2008-05-02

ApplicantAesku Diagnostics
Decision Date2008-05-02
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKULISA ANA HEP-2, REF 30-7115US is the device name listed in this FDA 510(k) record. The listed applicant is Aesku Diagnostics. It received FDA 510(k) clearance on 2008-05-02 under 510(k) number K081104. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESKULISA ANA HEP-2, REF 30-7115US?

AESKULISA ANA HEP-2, REF 30-7115US is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Aesku Diagnostics. The 510(k) number is K081104.

When did AESKULISA ANA HEP-2, REF 30-7115US receive FDA 510(k) clearance?

AESKULISA ANA HEP-2, REF 30-7115US received FDA 510(k) clearance on 2008-05-02, under 510(k) number K081104.

Who is the listed applicant for AESKULISA ANA HEP-2, REF 30-7115US?

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 ANA HEP-2, REF 30-7115US?

The FDA product code for AESKULISA ANA HEP-2, REF 30-7115US is LKJ.

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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 GK052439AESKULISA GLIA A AND AESKULISA GLIA G

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Related Devices (Code: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, Inc.K034013REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001Corgenix, 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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