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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Herpesvirus Hominis 1,2
510(k) Number K841680
Device Name SCOTT SELECTICULT-HSV ISOLATION &
Applicant
Scott Laboratories, Inc.
Fiskeville,  RI  02823
Applicant Contact THOMAS W KELLEY
Correspondent
Scott Laboratories, Inc.
Fiskeville,  RI  02823
Correspondent Contact THOMAS W KELLEY
Regulation Number866.3305
Classification Product Code
GQL  
Date Received04/23/1984
Decision Date 10/30/1984
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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