Cleared Traditional

BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT

K042579 · The Binding Site · Immunology
Jul 2005
Decision
309d
Days
Class 2
Risk

About This 510(k) Submission

K042579 is an FDA 510(k) clearance for the BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT, a Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (Class II — Special Controls, product code NBT), submitted by The Binding Site (Santa Monica, US). The FDA issued a Cleared decision on July 28, 2005, 309 days after receiving the submission on September 22, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5785.

Submission Details

510(k) Number K042579 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2004
Decision Date July 28, 2005
Days to Decision 309 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code NBT — Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5785

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