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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K851378
Device Name VIRTRAN VIRAL TRANPORTER
Applicant
Diagnon Corp.
Phair Office Park
1050 W. St.
Laurel,  MD  20707
Applicant Contact MARIE T PERLSTEIN
Correspondent
Diagnon Corp.
Phair Office Park
1050 W. St.
Laurel,  MD  20707
Correspondent Contact MARIE T PERLSTEIN
Regulation Number866.2900
Classification Product Code
LIO  
Date Received04/08/1985
Decision Date 06/21/1985
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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