BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS— 510(k) K040466

Name: FDA 510(k) clearance K040466
Creator: U.S. Food and Drug Administration
Published: 2004-07-16

Substantially Equivalent

The Binding Site

FDA 510(k) clearance K040466 for BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS, Substantially Equivalent on 2004-07-16. Applicant: The Binding Site. Device class: 2.

Clearance details

Applicant: The Binding Site
Product code: Code MVM
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2004-02-23
Decision date: 2004-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.