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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 K920150
Device Name ENCORE SCL-70
Applicant
Clark Laboratories, Inc.
53 Cedar Lake Rd.
Blairstown,  NJ  07825
Applicant Contact Gary Lehnus
Correspondent
Clark Laboratories, Inc.
53 Cedar Lake Rd.
Blairstown,  NJ  07825
Correspondent Contact Gary Lehnus
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received01/13/1992
Decision Date 03/18/1992
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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