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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Staphylococcus Aureus
510(k) Number K905617
Device Name VISI-STAPH
Applicant
Connecticut Diagnostics, Ltd.
36c Beatrice Ave.
Danielson,  CT  06239
Applicant Contact JOHN ABRAHAM
Correspondent
Connecticut Diagnostics, Ltd.
36c Beatrice Ave.
Danielson,  CT  06239
Correspondent Contact JOHN ABRAHAM
Regulation Number866.2660
Classification Product Code
JWX  
Date Received12/14/1990
Decision Date 03/29/1991
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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