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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 K920920
Device Name ELISA TUBE LH TEST KIT
Applicant
BIO CLINIC CO.
5977 SOUTHWEST AVE.
ST. LOUIS,  MI  63139
Applicant Contact BRUCE F WATKINS
Correspondent
BIO CLINIC CO.
5977 SOUTHWEST AVE.
ST. LOUIS,  MI  63139
Correspondent Contact BRUCE F WATKINS
Regulation Number862.1485
Classification Product Code
CEP  
Date Received02/28/1992
Decision Date 04/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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