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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 K860247
Device Name INSTA KIT FOR GROUP A STREP ID
Applicant
Mead Johnson & Co.
Evansville,  IN  47721
Applicant Contact THOMAS A SWINFORD
Correspondent
Mead Johnson & Co.
Evansville,  IN  47721
Correspondent Contact THOMAS A SWINFORD
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received01/24/1986
Decision Date 03/04/1986
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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