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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 K000810
Device Name QUALITROL LIPID CONTROL, LEVELS 1 AND 2
Applicant
Consolidated Technologies of Wisconsin
2170 Woodward St.
Austin,  TX  78744
Applicant Contact RUSTY SEWELL
Correspondent
Consolidated Technologies of Wisconsin
2170 Woodward St.
Austin,  TX  78744
Correspondent Contact RUSTY SEWELL
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/13/2000
Decision Date 04/13/2000
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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