Cleared Traditional

ATHENA MULTI-LYTE GBM TEST SYSTEM

K071219 · Zeus Scientific, Inc. · Immunology

Dec 2007

Decision

218d

Days

Class 2

Risk

About This 510(k) Submission

K071219 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE GBM TEST SYSTEM, a Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (Class II — Special Controls, product code MVJ), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 6, 2007, 218 days after receiving the submission on May 2, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K071219 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2007
Decision Date	December 06, 2007
Days to Decision	218 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