Cleared Traditional

K954062 - EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
(FDA 510(k) Clearance)

K954062 · Scimedx Corp. · Immunology

Mar 1996

Decision

203d

Days

Class 2

Risk

K954062 is an FDA 510(k) clearance for the EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on March 19, 1996, 203 days after receiving the submission on August 29, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K954062 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 1995
Decision Date	March 19, 1996
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement