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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 K853837
Device Name LH/FSH RADIOIMMUNOASSAY KIT
Applicant
Bioclinical Group
45 Spinelli Place
Cambridge,  MA  02138
Applicant Contact MARK C ROESSEL
Correspondent
Bioclinical Group
45 Spinelli Place
Cambridge,  MA  02138
Correspondent Contact MARK C ROESSEL
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/16/1985
Decision Date 10/16/1985
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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