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FDA 510(k)

TECHLAB ASCA-CHEK

K-Number: K051927 · 2006-04-06

ApplicantTechlab, Inc.
Decision Date2006-04-06
Product CodeNBT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TECHLAB ASCA-CHEK is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2006-04-06 under 510(k) number K051927. 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 TECHLAB ASCA-CHEK?

TECHLAB ASCA-CHEK is a medical device that received FDA 510(k) clearance on 2006-04-06. The listed applicant is Techlab, Inc.. The 510(k) number is K051927.

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

TECHLAB ASCA-CHEK received FDA 510(k) clearance on 2006-04-06, under 510(k) number K051927.

Who is the listed applicant for TECHLAB ASCA-CHEK?

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

What is the FDA product code for TECHLAB ASCA-CHEK?

The FDA product code for TECHLAB ASCA-CHEK is NBT.

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Other records listing Techlab, Inc. as applicant

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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 CenterK051492AESKULISA 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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