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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 K903406
Device Name VIRAL ACCU-CULSHURE TM
Applicant
Medical Laboratory Automation Systems, Inc.
270 Marble Ave.
Pleasantville,  NY  10570
Applicant Contact JOANN HANCHROW
Correspondent
Medical Laboratory Automation Systems, Inc.
270 Marble Ave.
Pleasantville,  NY  10570
Correspondent Contact JOANN HANCHROW
Regulation Number866.2900
Classification Product Code
LIO  
Date Received07/31/1990
Decision Date 10/16/1990
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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