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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 K964694
Device Name ELECSYS LH ASSAY
Applicant
Boehringer Mannheim Corp.
2400 Bisso Ln.
Concord,  CA  94524
Applicant Contact BETSY SOARES-MADDOX
Correspondent
Boehringer Mannheim Corp.
2400 Bisso Ln.
Concord,  CA  94524
Correspondent Contact BETSY SOARES-MADDOX
Regulation Number862.1485
Classification Product Code
CEP  
Date Received11/22/1996
Decision Date 01/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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