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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, For Clinical Use
510(k) Number K926131
Device Name OPUS MAGNUM ANALYZER
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 Number862.2560
Classification Product Code
KHO  
Date Received12/07/1992
Decision Date 06/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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