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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 K952727
Device Name MRC-5 CELL CULTURE VIAL
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 Received06/14/1995
Decision Date 11/20/1995
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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