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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram Positive Identification Panel
510(k) Number K910537
Device Name VISI-STREP
Applicant
Kev Connecticut Diagnostics, Inc.
36c Beatrice Ave.
Danielson,  CT  06239
Applicant Contact MENASHI COHENFORD
Correspondent
Kev Connecticut Diagnostics, Inc.
36c Beatrice Ave.
Danielson,  CT  06239
Correspondent Contact MENASHI COHENFORD
Regulation Number866.2660
Classification Product Code
LQL  
Date Received02/08/1991
Decision Date 04/12/1991
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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