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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Collection, Capillary Blood
510(k) Number K894851
Device Name TRU-TRAX
Applicant
Humagen, Inc.
1500 Avon St. Extended
Charlottesville,  VA  22901
Applicant Contact BRYANT, PHD
Correspondent
Humagen, Inc.
1500 Avon St. Extended
Charlottesville,  VA  22901
Correspondent Contact BRYANT, PHD
Regulation Number864.6150
Classification Product Code
GIO  
Date Received07/31/1989
Decision Date 09/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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