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FDA 510(k)

BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT

K-Number: K042579 · 2005-07-28

ApplicantThe Binding Site
Decision Date2005-07-28
Product CodeNBT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site. It received FDA 510(k) clearance on 2005-07-28 under 510(k) number K042579. 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 BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT?

BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT is a medical device that received FDA 510(k) clearance on 2005-07-28. The listed applicant is The Binding Site. The 510(k) number is K042579.

When did BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT receive FDA 510(k) clearance?

BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT received FDA 510(k) clearance on 2005-07-28, under 510(k) number K042579.

Who is the listed applicant for BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT?

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

What is the FDA product code for BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT?

The FDA product code for BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT 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.

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Other records listing The Binding Site 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.

K132555HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITK103824HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSK100455SPAPLUS ANALYZERK092450HUMAN IGD KIT FOR USE ON SPAPLUSK072166CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERK042152BINDING SITE IGG SUBLCASS OLYMPUS KITS

View all 9 devices →

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.K051492AESKULISA ASCA AAesku, Inc.K032860IMMULISA 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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