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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 K001249
Device Name QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3
Applicant
CONSOLIDATED TECHNOLOGIES OF WISCONSIN
2170 WOODWARD ST.
AUSTIN,  TX  78744 -1832
Applicant Contact RUSTY SEWELL
Correspondent
CONSOLIDATED TECHNOLOGIES OF WISCONSIN
2170 WOODWARD ST.
AUSTIN,  TX  78744 -1832
Correspondent Contact RUSTY SEWELL
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/12/2000
Decision Date 11/02/2000
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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