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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 K860333
Device Name MICRO-ELISA HLH TEST KIT MONOCLONAL
Applicant
Bioclinical Systems, Inc.
5977 Southwest Ave.
St.Louis,  MO  63139
Applicant Contact WATKINS, PH.D.
Correspondent
Bioclinical Systems, Inc.
5977 Southwest Ave.
St.Louis,  MO  63139
Correspondent Contact WATKINS, PH.D.
Regulation Number862.1485
Classification Product Code
CEP  
Date Received01/29/1986
Decision Date 04/21/1986
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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