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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Neisseria Gonorrhoeae
510(k) Number K913456
Device Name VISI-NEISSERIA
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
JSX  
Date Received08/05/1991
Decision Date 10/11/1991
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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