Aeskulisa Asca a

FDA 510(k) K051492 · Aesku, Inc.

Substantially Equivalent

510(k) numberK051492

Submission

Device name
Aeskulisa Asca a
Applicant
Aesku, Inc.
Miami, FL, US
Received
June 6, 2005
Decision date
November 14, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NBT – Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5785
Specialty
Immunology

Other 510(k)s with product code NBT

510(k)DeviceApplicantDecision
K071711Asca-ChekNBT · Traditional Techlab Inc., Corporate Research Center11/07/2007SE
K051927Techlab Asca-ChekNBT · Traditional Techlab, Inc.04/06/2006SE
K042579Bindazyme Human Asca Igg and Iga Eia Diagnostic Test KitNBT · Traditional The Binding Site07/28/2005SE
K032860Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga)NBT · Traditional Immco Diagnostics, Inc.03/18/2004SE
K032850Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg)NBT · Traditional Immco Diagnostics, Inc.03/18/2004SE
K000733Quanta Lite Asca (S. Cerevisiae) Iga ElisaNBT · Traditional Inova Diagnostics, Inc.05/21/2001SE

More from Inova Diagnostics, Inc.

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K062217Aeskulska BETA2-GLYCO-AMSV · Traditional 12/13/2006SE
K042644Aeskulisa TTG a and Aeskulisa TTG GMVM · Traditional 06/01/2005SE
K040953Aeskulisa Ana HEP-2LJM · Traditional 06/23/2004SE
K040463Aeskulisa Cardiolipin AgmMID · Traditional 05/12/2004SE
K032469Aeskulisa Ana 8PROLLL · Traditional 12/16/2003SE

Questions and answers

When was Aeskulisa Asca a cleared by the FDA?

Aeskulisa Asca a (K051492) received a 510(k) decision of Substantially Equivalent on November 14, 2005, 161 days after the submission was received.

What is the product code of K051492?

The FDA product code is NBT – Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae), a Class II (moderate risk) device regulated under 21 CFR 866.5785.