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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rubella
510(k) Number K915870
Device Name OPUS RUBELLA TEST SYSTEM
Applicant
Pb Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact KATHLEEN DRAY-LYONS
Correspondent
Pb Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact KATHLEEN DRAY-LYONS
Regulation Number866.3510
Classification Product Code
LFX  
Date Received12/31/1991
Decision Date 03/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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