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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 K881457
Device Name KODAK SURECELL STREP A TEST KIT
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact NORMAN H GEIL
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact NORMAN H GEIL
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received04/06/1988
Decision Date 04/21/1988
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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