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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K801159
Device Name STREPTO-SEC TM
Applicant
Organon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Organon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received05/11/1980
Decision Date 06/20/1980
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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