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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K811465
Device Name IMIPRAMINE/DISIPRAMINE/LITHIUM
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
125 MARK AVENUE
CARPINTERIA,  CA  93013 -
Correspondent
ORTHO DIAGNOSTIC SYSTEMS, INC.
125 MARK AVENUE
CARPINTERIA,  CA  93013 -
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/26/1981
Decision Date 06/12/1981
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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