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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Syncytial Virus, Antigen, Antibody, Ifa
510(k) Number K872082
Device Name RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
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 Number866.3480
Classification Product Code
LKT  
Date Received05/29/1987
Decision Date 07/31/1987
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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