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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Conjugated Fluorescent, Cytomegalovirus
510(k) Number K905257
Device Name OPUS CMV TEST SYSTEM
Applicant
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact DRAY LYONS
Correspondent
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact DRAY LYONS
Regulation Number866.3175
Classification Product Code
LIN  
Date Received11/21/1990
Decision Date 04/17/1991
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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