Asca-Chek

FDA 510(k) K071711 · Techlab Inc., Corporate Research Center

Substantially Equivalent

510(k) numberK071711

Submission

Device name
Asca-Chek
Applicant
Techlab Inc., Corporate Research Center
Blacksburg, VA, US
Received
June 22, 2007
Decision date
November 7, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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
K051927Techlab Asca-ChekNBT · Traditional Techlab, Inc.04/06/2006SE
K051492Aeskulisa Asca aNBT · Traditional Aesku, Inc.11/14/2005SE
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.

510(k)DeviceDecision
K121411Shiga Toxin ChekGMZ · Traditional 10/02/2012SE
K121364Shiga Toxin Quik ChekGMZ · Traditional 10/02/2012SE
K103673Giardia/ Cryptosporidium Quik ChekMHI · Traditional 08/18/2011SE
K071712Leuko Ez VueDEG · Traditional 12/04/2007SE

Questions and answers

When was Asca-Chek cleared by the FDA?

Asca-Chek (K071711) received a 510(k) decision of Substantially Equivalent on November 7, 2007, 138 days after the submission was received.

What is the product code of K071711?

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