WELLCOLEX E-COLI OI57 ZC60— 510(k) K962028

Name: FDA 510(k) clearance K962028
Creator: U.S. Food and Drug Administration
Published: 1996-11-01

Substantially Equivalent

Murex Diagnostics, Inc.

FDA 510(k) clearance K962028 for WELLCOLEX E-COLI OI57 ZC60, Substantially Equivalent on 1996-11-01. Applicant: Murex Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Murex Diagnostics, Inc.
Product code: Code GNA
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1996-05-23
Decision date: 1996-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GNA

view all

K071799 — MODIFICATION TO BIOSTAR OIA SHIGATOX2007-10-02
K031367 — DUOPATH VEROTOXINS GLISA TEST2004-01-23
K993401 — DRYSPOT E.COLI 0157 KIT2000-02-28
K981734 — VTEC-RPLA SEIKEN1998-09-22
K953362 — PREMIER EHEC1995-11-14

More clearances from Murex Diagnostics, Inc.

view all

K954920 — MUREX RUB-EX1996-08-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.