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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Epstein-Barr Virus, Other
510(k) Number K921628
Device Name EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
Applicant
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082 -0285
Applicant Contact MARY FRICK
Correspondent
Incstar Corp.
1990 Insustrial Blvd.
P.O. Box 285
Stillwater,  MN  55082 -0285
Correspondent Contact MARY FRICK
Regulation Number866.3235
Classification Product Code
LSE  
Date Received04/06/1992
Decision Date 09/14/1992
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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