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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Antigen, Nuclear, Epstein-Barr Virus
510(k) Number K946158
Device Name INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
Applicant
Incstar Corp.
1990 Industrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact MARY L FRICK
Correspondent
Incstar Corp.
1990 Industrial Blvd.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact MARY L FRICK
Regulation Number866.3235
Classification Product Code
LLM  
Date Received12/08/1994
Decision Date 06/09/1995
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
Recalls CDRH Recalls
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