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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
510(k) Number K854108
Device Name POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO
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 Number866.3300
Classification Product Code
LHL  
Date Received10/08/1985
Decision Date 11/12/1985
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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