FDA.reportPublic FDA data

510(k) K222829

Device
Curian® Shiga Toxin
Applicant
Meridian Bioscience, Inc.
510(k) number
K222829
Product code
GMZ
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-17
Date received
2022-09-19
Regulation
866.3255
Classification name
Antigens, All Types, Escherichia Coli
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Heather Planck
Address
3471 River Hills Dr. Cincinnati OH US 45244 45244

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GMZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121364SHIGA TOXIN QUIK CHEKTechlab Inc., Corporate Research Center2012-10-02
K121411SHIGA TOXIN CHEKTechlab Inc., Corporate Research Center2012-10-02
K062546IMMUNOCARD STAT! EHEC, MODEL 751630Meridian Bioscience, Inc.2007-02-14
K061889BIOSTAR OIA SHIGATOXInverness Medical-Biostar, Inc.2006-12-12
K023599IMMUNOCARD STAT! E. COLI O157 PLUSMeridian Bioscience, Inc.2003-01-03
K990263IMMUNOCARD STAT! E. COLI O157:H7Meridian Diagnostics, Inc.1999-08-09
K980507PROSPECT SHIGA TOXIN MICROPLATE ASSAYAlexon - Trend, Inc.1998-04-23
K973457CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800Shared Systems, Inc.1998-01-02
K971663WELLCOLEX E.COLI O157:H7Murex Biotech , Ltd.1997-12-30
K972156QUIX RAPID E. COLI O157 STRIP TESTGuardian Scientific, Corp.1997-10-16
K942705E. COLI 0157 ELISA STOOL ASSAYLmd Laboratories1995-09-27
K944421E.COLI 0157 LATEX TESTPro-Lab Diagnostics1994-12-15
K884513PF TESTMedi-Tech, Inc.1989-02-03