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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
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