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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 K873249
Device Name ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS
Applicant
Cytotech, Inc.
11035 Roselle St., Suite A
San Diego,  CA  92121
Applicant Contact KIEHL, PHD
Correspondent
Cytotech, Inc.
11035 Roselle St., Suite A
San Diego,  CA  92121
Correspondent Contact KIEHL, PHD
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received08/17/1987
Decision Date 09/22/1987
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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