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FDA 510(k)

AESKULISA ASCA A

K-Number: K051492 · 2005-11-14

ApplicantAesku, Inc.
Decision Date2005-11-14
Product CodeNBT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKULISA ASCA A is the device name listed in this FDA 510(k) record. The listed applicant is Aesku, Inc.. It received FDA 510(k) clearance on 2005-11-14 under 510(k) number K051492. The device is classified under product code NBT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESKULISA ASCA A?

AESKULISA ASCA A is a medical device that received FDA 510(k) clearance on 2005-11-14. The listed applicant is Aesku, Inc.. The 510(k) number is K051492.

When did AESKULISA ASCA A receive FDA 510(k) clearance?

AESKULISA ASCA A received FDA 510(k) clearance on 2005-11-14, under 510(k) number K051492.

Who is the listed applicant for AESKULISA ASCA A?

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 ASCA A?

The FDA product code for AESKULISA ASCA A is NBT.

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-AK042644AESKULISA TTG A AND AESKULISA TTG GK040953AESKULISA ANA HEP-2K040463AESKULISA CARDIOLIPIN AGMK032469AESKULISA ANA 8PRO

Related Devices (Code: NBT)

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.

K071711ASCA-CHEKTechlab Inc., Corporate Research CenterK051927TECHLAB ASCA-CHEKTechlab, Inc.K042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITThe Binding SiteK032860IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)Immco Diagnostics, Inc.K032850IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)Immco Diagnostics, Inc.K000733QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISAInova 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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