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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 K893605
Device Name SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
Applicant
Serono-Baker Diagnostics, Inc.
100 Cascade Dr.
Allentown,  PA  18103 -9562
Applicant Contact TOMALESKY
Correspondent
Serono-Baker Diagnostics, Inc.
100 Cascade Dr.
Allentown,  PA  18103 -9562
Correspondent Contact TOMALESKY
Regulation Number862.1485
Classification Product Code
CEP  
Date Received05/10/1989
Decision Date 06/20/1989
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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