510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GMZClass I

Antigens, All Types, Escherichia Coli

21 CFR 866.3255 / Microbiology
FDA source (opens on fda.gov)

GMZ is the FDA product code for Antigens, All Types, Escherichia Coli, a class I device type, regulated under 21 CFR 866.3255. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GMZ
Device name
Antigens, All Types, Escherichia Coli
Regulation
21 CFR 866.3255
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
2

Clearances, product code GMZ

By decision year
14 clearances under product code GMZ with a decision year between 1989 and 2023, 1997 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GMZ by decision year
YearClearances
19891
19941
19951
19972
19982
19991
20031
20061
20071
20122
20231

Applicants with the most clearances

Product code GMZ
Applicants holding the most 510(k) clearances under product code GMZ
ApplicantClearances
Meridian Bioscience Inc3
Techlab Inc., Corporate Research Center2
Alexon - Trend, Inc.1
Guardian Scientific, Corp.1
Inverness Medical-Biostar, Inc.1
Lmd Laboratories1
Medi-Tech, Inc.1
Meridian Diagnostics, Inc.1
Murex Biotech, Ltd.1
Pro-Lab Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code