GMZ · Class I · 21 CFR 866.3255

FDA Product Code GMZ: Antigens, All Types, Escherichia Coli

Leading manufacturers include Meridian Bioscience, Inc., Techlab Inc., Corporate Research Center and Alexon - Trend, Inc..

14
Total
14
Cleared
167d
Avg days
1989
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Antigens, All Types, Escherichia Coli Devices (Product Code GMZ)

14 devices
1–14 of 14
Cleared Apr 17, 2023
Curian® Shiga Toxin
K222829
Meridian Bioscience, Inc.
Microbiology · 210d
Cleared Oct 02, 2012
SHIGA TOXIN QUIK CHEK
K121364
Techlab Inc., Corporate Research Center
Microbiology · 148d
Cleared Oct 02, 2012
SHIGA TOXIN CHEK
K121411
Techlab Inc., Corporate Research Center
Microbiology · 144d
Cleared Feb 14, 2007
IMMUNOCARD STAT! EHEC, MODEL 751630
K062546
Meridian Bioscience, Inc.
Microbiology · 168d
Cleared Jan 03, 2003
IMMUNOCARD STAT! E. COLI O157 PLUS
K023599
Meridian Bioscience, Inc.
Microbiology · 67d
Cleared Aug 09, 1999
IMMUNOCARD STAT! E. COLI O157:H7
K990263
Meridian Diagnostics, Inc.
Microbiology · 194d
Cleared Apr 23, 1998
PROSPECT SHIGA TOXIN MICROPLATE ASSAY
K980507
Alexon - Trend, Inc.
Microbiology · 72d
Cleared Jan 02, 1998
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
K973457
Shared Systems, Inc.
Microbiology · 112d
Cleared Dec 30, 1997
WELLCOLEX E.COLI O157:H7
K971663
Murex Biotech , Ltd.
Microbiology · 238d
Cleared Oct 16, 1997
QUIX RAPID E. COLI O157 STRIP TEST
K972156
Guardian Scientific, Corp.
Microbiology · 129d
Cleared Feb 03, 1989
PF TEST
K884513
Medi-Tech, Inc.
Microbiology · 99d

About Product Code GMZ - Regulatory Context

510(k) Submission Activity

14 total 510(k) submissions under product code GMZ since 1989, with 14 receiving FDA clearance (average review time: 167 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.