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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 K033344
Device Name LIGAND PLUS CONTROL LEVEL 1-3
Applicant
Consolidated Technology
4401 Freidrich Ln. Bldg. 1
Suite 100
Austin,  TX  78744
Applicant Contact CANDICE BETZ
Correspondent
Consolidated Technology
4401 Freidrich Ln. Bldg. 1
Suite 100
Austin,  TX  78744
Correspondent Contact CANDICE BETZ
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/20/2003
Decision Date 01/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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