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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Glucagon
510(k) Number K893975
Device Name DOUBLE ANTIBODY GLUCAGON
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact KENNETH ASARCH
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact KENNETH ASARCH
Regulation Number862.1335
Classification Product Code
JME  
Date Received06/02/1989
Decision Date 10/31/1989
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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