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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Elisa, Cryptococcus
510(k) Number K904393
Device Name PREMIER-CRYPTOCOCCAL ANTIGEN
Applicant
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact ALLEN NICKOL
Correspondent
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact ALLEN NICKOL
Regulation Number866.3165
Classification Product Code
MDU  
Date Received09/25/1990
Decision Date 01/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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