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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Antigen, Control
510(k) Number K961815
Device Name QUALITROL ANA CONTROL SERUM 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 Number866.5100
Classification Product Code
LKJ  
Date Received05/10/1996
Decision Date 09/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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