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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 And Negative Febrile Antigen Control Serum
510(k) Number K791385
Device Name NEGATIVE CONTROL SERUM FOR CF RO ID
Applicant
Immuno-Mycologics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Immuno-Mycologics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3085
Classification Product Code
GSN  
Date Received07/11/1979
Decision Date 08/16/1979
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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