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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 K891542
Device Name EBNA-CHECK(TM) TEST KIT
Applicant
Diagnostic Technology, Inc.
240 Vanderbilt Motor Pkwy.
Hauppauge,  NY  11788
Applicant Contact ROBERT E LIND
Correspondent
Diagnostic Technology, Inc.
240 Vanderbilt Motor Pkwy.
Hauppauge,  NY  11788
Correspondent Contact ROBERT E LIND
Regulation Number866.3235
Classification Product Code
LLM  
Date Received03/17/1989
Decision Date 06/20/1989
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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