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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 K961912
Device Name QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET
Applicant
Consolidated Technologies, Inc.
2170 Woodward St., Suite 100
Austin,  TX  78744
Applicant Contact WILLIAM CONE
Correspondent
Consolidated Technologies, Inc.
2170 Woodward St., Suite 100
Austin,  TX  78744
Correspondent Contact WILLIAM CONE
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/17/1996
Decision Date 08/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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