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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K924056
Device Name ENCORE RHEUMATOID FACTOR EIA
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 Number866.5775
Classification Product Code
DHR  
Date Received08/12/1992
Decision Date 09/25/1992
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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