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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Serological, Positive Control
510(k) Number K934137
Device Name OPUS(R) SEROLOGY CONTROLS, MODIFICATION
Applicant
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact NANCY M JOHANSEN
Correspondent
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact NANCY M JOHANSEN
Regulation Number862.1660
Classification Product Code
MJX  
Subsequent Product Code
MJY  
Date Received08/25/1993
Decision Date 03/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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