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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Epstein-Barr Virus
510(k) Number K854207
Device Name EBV(EPSTEIN-BARR VIRUS) TEST KIT
Applicant
Immuno-Diagnostic Products, Inc.
P.O. Box 193
54 S. 130 E.
North Salt Lake,  UT  84054
Applicant Contact NADEEM M MUNA
Correspondent
Immuno-Diagnostic Products, Inc.
P.O. Box 193
54 S. 130 E.
North Salt Lake,  UT  84054
Correspondent Contact NADEEM M MUNA
Regulation Number866.3235
Classification Product Code
GNP  
Date Received10/16/1985
Decision Date 04/24/1986
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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