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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 K873114
Device Name CYTOMEGALOVIRUS CONTROL SLIDES
Applicant
Medical Diagnostic Technologies, Inc.
3351 Wrightsboro Rd.
Suite 502
Augusta,  GA  30909
Applicant Contact DAVID A WALL
Correspondent
Medical Diagnostic Technologies, Inc.
3351 Wrightsboro Rd.
Suite 502
Augusta,  GA  30909
Correspondent Contact DAVID A WALL
Regulation Number866.3175
Classification Product Code
GQH  
Date Received08/10/1987
Decision Date 09/25/1987
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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