Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AESKULISA CARDIOLIPIN AGM

K-Number: K040463 · 2004-05-12

ApplicantAesku, Inc.
Decision Date2004-05-12
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKULISA CARDIOLIPIN AGM is the device name listed in this FDA 510(k) record. The listed applicant is Aesku, Inc.. It received FDA 510(k) clearance on 2004-05-12 under 510(k) number K040463. The device is classified under product code MID. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESKULISA CARDIOLIPIN AGM?

AESKULISA CARDIOLIPIN AGM is a medical device that received FDA 510(k) clearance on 2004-05-12. The listed applicant is Aesku, Inc.. The 510(k) number is K040463.

When did AESKULISA CARDIOLIPIN AGM receive FDA 510(k) clearance?

AESKULISA CARDIOLIPIN AGM received FDA 510(k) clearance on 2004-05-12, under 510(k) number K040463.

Who is the listed applicant for AESKULISA CARDIOLIPIN AGM?

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

What is the FDA product code for AESKULISA CARDIOLIPIN AGM?

The FDA product code for AESKULISA CARDIOLIPIN AGM is MID.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aesku, Inc. 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.

K062217AESKULSKA BETA2-GLYCO-AK051492AESKULISA ASCA AK042644AESKULISA TTG A AND AESKULISA TTG GK040953AESKULISA ANA HEP-2K032469AESKULISA ANA 8PRO

Related Devices (Code: MID)

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.

K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYPhadia US, Inc.K130528BIOPLEX 2200 APLS IGMBio-Rad LaboratoriesK120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAInova Diagnostics, Inc.K113020IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASImmco Diagnostics, Inc.K103834BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSBio-Rad Laboratories

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.

↑