Cleared Traditional

BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT

K984619 · The Binding Site, Ltd. · Immunology
Feb 1999
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K984619 is an FDA 510(k) clearance for the BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT, a Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (Class II — Special Controls, product code MVJ), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on February 23, 1999, 56 days after receiving the submission on December 29, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K984619 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1998
Decision Date February 23, 1999
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MVJ — Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660