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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Latex Agglutination, Cryptococcus Neoformans
510(k) Number K894845
Device Name (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
Applicant
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact WAYNE GADE
Correspondent
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact WAYNE GADE
Regulation Number866.3165
Classification Product Code
GMD  
Date Received08/11/1989
Decision Date 09/08/1989
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
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