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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 K961293
Device Name QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2
Applicant
CONSOLIDATED TECHNOLOGIES, INC.
2170 WOODWARD STREET, STE. 100
AUSTIN,  TX  78744 -1832
Applicant Contact WILLIAM CONE
Correspondent
CONSOLIDATED TECHNOLOGIES, INC.
2170 WOODWARD STREET, STE. 100
AUSTIN,  TX  78744 -1832
Correspondent Contact WILLIAM CONE
Regulation Number862.1660
Classification Product Code
JJY  
Subsequent Product Code
DIF  
Date Received04/04/1996
Decision Date 05/02/1996
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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