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510(k) K974881

Device
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
Applicant
BIOSITE INCORPORATED
510(k) number
K974881
Product code
MCB  
Decision
Substantially Equivalent (SESE)
Decision date
1998-03-20
Date received
1997-12-30
Regulation
866.2660
Classification name
Antigen, C. Difficile
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHN F BRUNI
Address
11030 Roselle St. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MCB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132010VIDAS C DIFFICILE GDHBiomerieux S.A.2013-10-09
K112048IMMUNOCARD C. DIFFICILE GDHMeridian Bioscience, Inc.2011-12-16
K110620PREMIER C. DIFFICILE GDHMeridian Bioscience, Inc.2011-05-03
K053572C. DIFF QUIK CHEKTechlab, Inc.2006-04-26
K955067CLEARVIEW C. DIFF AUnipath , Ltd.1996-09-13
K924062MERITEC C. DIFFICILE CONTROLSMeridian Diagnostics, Inc.1992-10-19
K904329CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAYBaxter Healthcare Corp1991-03-12
K895915MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEMMeridian Diagnostics, Inc.1990-03-12
K833447CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-Bartels Immunodiagnostic Supplies, Inc.1984-05-21

Legacy Summary#

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FDA Review#

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