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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cells, Animal And Human, Cultured
510(k) Number K955921
Device Name A549 CELL CULTURE
Applicant
Viratest Intl., Inc.
7540 Louis Pasteur, Suite 205
San Antonio,  TX  78229
Applicant Contact WILLIAM J NORTHAM
Correspondent
Viratest Intl., Inc.
7540 Louis Pasteur, Suite 205
San Antonio,  TX  78229
Correspondent Contact WILLIAM J NORTHAM
Regulation Number864.2280
Classification Product Code
KIR  
Date Received12/14/1995
Decision Date 02/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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