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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 K851372
Device Name CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS
Applicant
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Applicant Contact WALTER S FISHER
Correspondent
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Correspondent Contact WALTER S FISHER
Regulation Number866.3305
Classification Product Code
GQL  
Date Received04/08/1985
Decision Date 07/12/1985
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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