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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 K882340
Device Name LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
Applicant
SERONO DIAGNOSTICS, INC.
100 LONGWATER CIRCLE
NORWELL,  MA  02061
Applicant Contact PHILIP M FANTASIA
Correspondent
SERONO DIAGNOSTICS, INC.
100 LONGWATER CIRCLE
NORWELL,  MA  02061
Correspondent Contact PHILIP M FANTASIA
Regulation Number862.1485
Classification Product Code
CEP  
Date Received06/07/1988
Decision Date 08/08/1988
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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