Cleared Traditional

PHASE II GBM IGG ANTIBODY EIA TEST

K011348 · Scimedx Corp. · Immunology

Jun 2001

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K011348 is an FDA 510(k) clearance for the PHASE II GBM IGG ANTIBODY EIA TEST, a Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (Class II — Special Controls, product code MVJ), submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on June 25, 2001, 54 days after receiving the submission on May 2, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K011348 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2001
Decision Date	June 25, 2001
Days to Decision	54 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