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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
510(k) Number K883684
Device Name HERPES VIRUS CONTROL SLIDES
Applicant
Val Tech Diagnostics, Inc.
14 Werner Camp Rd.
Pittsburgh,  PA  15215
Applicant Contact STEVE L SINKA
Correspondent
Val Tech Diagnostics, Inc.
14 Werner Camp Rd.
Pittsburgh,  PA  15215
Correspondent Contact STEVE L SINKA
Regulation Number866.3305
Classification Product Code
GQN  
Date Received08/29/1988
Decision Date 09/28/1988
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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