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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Positive Control, Histoplasma Capsulatum
510(k) Number K792694
Device Name NEGATIVE CONTROL SERUM
Applicant
Meridian Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Meridian Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3320
Classification Product Code
GMK  
Date Received12/27/1979
Decision Date 01/24/1980
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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