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CLIA record K923859 and corresponding
510(K) Premarket Notification information

Test System NameMeridian Diagnostics Premier Blastomyces EIA  
Document Number K923859
Analyte NameBlastomyces Antibodies
Analyte SpecialtyGeneral Immunology
ComplexityHIGH
Effective Date11/22/1993

510(k) Premarket Notification Database

Device Classification Name eia, blastomyces dermatitidis
510(k) NumberK923859
Device NamePREMIER BLASTOMYCES
Applicant
MERIDIAN DIAGNOSTICS, INC.
3471 river hills dr.
cincinnati,  OH  45244
Contactallen d nickol
Regulation Number866.3060
Classification Product Code
MJL
Date Received07/31/1992
Decision Date 10/05/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Statement/Summary/Purged Status Summary only
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 01/16/2009

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