Atlas FDA

GMZ

14 FDA 510(k) clearances · Product code

148 daysmedian time to decision
238 days90th percentile
14clearances measured

FDA profile

Official device name
Antigens, All Types, Escherichia Coli
Device class
Class I (low risk)
Regulation
21 CFR 866.3255
Medical specialty
Microbiology
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RecordFirmDate
Curian® Shiga Toxin (K222829)Meridian Bioscience, Inc.2023-04-17
SHIGA TOXIN CHEK (K121411)Techlab Inc., Corporate Research Center2012-10-02
SHIGA TOXIN QUIK CHEK (K121364)Techlab Inc., Corporate Research Center2012-10-02
IMMUNOCARD STAT! EHEC, MODEL 751630 (K062546)Meridian Bioscience, Inc.2007-02-14
BIOSTAR OIA SHIGATOX (K061889)Inverness Medical-Biostar, Inc.2006-12-12
IMMUNOCARD STAT! E. COLI O157 PLUS (K023599)Meridian Bioscience, Inc.2003-01-03
IMMUNOCARD STAT! E. COLI O157:H7 (K990263)Meridian Diagnostics, Inc.1999-08-09
PROSPECT SHIGA TOXIN MICROPLATE ASSAY (K980507)Alexon - Trend, Inc.1998-04-23
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 (K973457)Shared Systems, Inc.1998-01-02
WELLCOLEX E.COLI O157:H7 (K971663)Murex Biotech , Ltd.1997-12-30
QUIX RAPID E. COLI O157 STRIP TEST (K972156)Guardian Scientific, Corp.1997-10-16
E. COLI 0157 ELISA STOOL ASSAY (K942705)Lmd Laboratories1995-09-27
E.COLI 0157 LATEX TEST (K944421)Pro-Lab Diagnostics1994-12-15
PF TEST (K884513)Medi-Tech, Inc.1989-02-03

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Every clearance here is in the API, with alerts when new ones post.