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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, C-Peptides Of Proinsulin
510(k) Number K943767
Device Name IMMULITE C-PEPTIDE
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact KENNETH B ASARCH, PHARM.D., PH.D.
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact KENNETH B ASARCH, PHARM.D., PH.D.
Regulation Number862.1135
Classification Product Code
JKD  
Date Received08/02/1994
Decision Date 03/23/1995
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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