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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K873400
Device Name PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
Applicant
Serono Diagnostics, Inc.
100 Longwater Cir.
Norwell,  MA  02061
Applicant Contact PHILIP M FANTASIA
Correspondent
Serono Diagnostics, Inc.
100 Longwater Cir.
Norwell,  MA  02061
Correspondent Contact PHILIP M FANTASIA
Regulation Number862.1625
Classification Product Code
CFT  
Date Received08/24/1987
Decision Date 09/25/1987
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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