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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K913938
Device Name OPUS(R) LH TEST SYSTEM
Applicant
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact LORI BARANAUSKAS
Correspondent
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact LORI BARANAUSKAS
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/03/1991
Decision Date 11/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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