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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf, All, Mycoplasma Spp.
510(k) Number K852933
Device Name MYCOPLASMA SPP SEROLOGICAL REAGENTS
Applicant
Microbix Biosystems, Inc.
341 Bering Ave.
Toronto, Ontario M9a 4x3
Canada,  CA
Applicant Contact WILLIAM J GASTLE
Correspondent
Microbix Biosystems, Inc.
341 Bering Ave.
Toronto, Ontario M9a 4x3
Canada,  CA
Correspondent Contact WILLIAM J GASTLE
Regulation Number866.3375
Classification Product Code
GSB  
Date Received07/09/1985
Decision Date 08/01/1985
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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