Cleared Traditional

WELLCOLEX E-COLI OI57 ZC60

K962028 · Murex Diagnostics, Inc. · Microbiology
Nov 1996
Decision
162d
Days
Class 1
Risk

About This 510(k) Submission

K962028 is an FDA 510(k) clearance for the WELLCOLEX E-COLI OI57 ZC60, a Antisera, All Types, Escherichia Coli (Class I — General Controls, product code GNA), submitted by Murex Diagnostics, Inc. (Norcross, US). The FDA issued a Cleared decision on November 1, 1996, 162 days after receiving the submission on May 23, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K962028 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 1996
Decision Date November 01, 1996
Days to Decision 162 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GNA — Antisera, All Types, Escherichia Coli
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3255