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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Human Placental Lactogen
510(k) Number K944933
Device Name IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact KENNETH B ASARCH
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact KENNETH B ASARCH
Regulation Number862.1585
Classification Product Code
JMF  
Subsequent Product Code
JJX  
Date Received10/06/1994
Decision Date 03/10/1995
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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