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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 K973469
Device Name QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS
Applicant
Consolidated Technologies, Inc.
2170 Woodward St., Suite 100
Austin,  TX  78744
Applicant Contact VIPIN D SHAH
Correspondent
Consolidated Technologies, Inc.
2170 Woodward St., Suite 100
Austin,  TX  78744
Correspondent Contact VIPIN D SHAH
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/04/1997
Decision Date 09/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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