Cleared Traditional

K953495 - EIA KIT FOR THE DETECTION OF GBM ANTIBODIES
(FDA 510(k) Clearance)

K953495 · Scimedx Corp. · Immunology

Apr 1996

Decision

259d

Days

Class 2

Risk

K953495 is an FDA 510(k) clearance for the EIA KIT FOR THE DETECTION OF GBM ANTIBODIES, a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBL), submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on April 10, 1996, 259 days after receiving the submission on July 26, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K953495 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 1995
Decision Date	April 10, 1996
Days to Decision	259 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5660