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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, Cytomegalovirus
510(k) Number K854666
Device Name CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
Applicant
Clinical Sciences, Inc.
30 Troy Rd.
Whippany,  NJ  07981
Applicant Contact MARYLOU PANICO
Correspondent
Clinical Sciences, Inc.
30 Troy Rd.
Whippany,  NJ  07981
Correspondent Contact MARYLOU PANICO
Regulation Number866.3175
Classification Product Code
GQI  
Date Received11/21/1985
Decision Date 02/05/1986
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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