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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Carbonic Anhydrase C, Antigen, Antiserum, Control
510(k) Number K902055
Device Name TENONE(TM) OPIATES CATALOG: VKSO1,4
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact B ASARCH,PHD
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact B ASARCH,PHD
Regulation Number866.5200
Classification Product Code
DDE  
Date Received05/07/1990
Decision Date 07/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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