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FDA 510(k)

ASCA-CHEK

K-Number: K071711 · 2007-11-07

ApplicantTechlab Inc., Corporate Research Center
Decision Date2007-11-07
Product CodeNBT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ASCA-CHEK is the device name listed in this FDA 510(k) record. The listed applicant is Techlab Inc., Corporate Research Center. It received FDA 510(k) clearance on 2007-11-07 under 510(k) number K071711. 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 ASCA-CHEK?

ASCA-CHEK is a medical device that received FDA 510(k) clearance on 2007-11-07. The listed applicant is Techlab Inc., Corporate Research Center. The 510(k) number is K071711.

When did ASCA-CHEK receive FDA 510(k) clearance?

ASCA-CHEK received FDA 510(k) clearance on 2007-11-07, under 510(k) number K071711.

Who is the listed applicant for ASCA-CHEK?

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

What is the FDA product code for ASCA-CHEK?

The FDA product code for ASCA-CHEK is NBT.

Other records listing Techlab Inc., Corporate Research Center 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.

K121364SHIGA TOXIN QUIK CHEKK121411SHIGA TOXIN CHEKK103673GIARDIA/ CRYPTOSPORIDIUM QUIK CHEKK071712LEUKO EZ VUE

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.

K051927TECHLAB ASCA-CHEKTechlab, Inc.K051492AESKULISA ASCA AAesku, 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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