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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), Cytomegalovirus
510(k) Number K964875
Device Name CMV ANTIGEN CONTROL SLIDES
Applicant
Viral Antigens, Inc.
5171 Wilfong Rd.
Memphis,  TN  38134
Applicant Contact TERRY S RATCLIFFE
Correspondent
Viral Antigens, Inc.
5171 Wilfong Rd.
Memphis,  TN  38134
Correspondent Contact TERRY S RATCLIFFE
Regulation Number866.3175
Classification Product Code
GQH  
Date Received12/05/1996
Decision Date 03/18/1997
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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