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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 K923771
Device Name PULSE RF TEST
Applicant
Pulse Scientific, Inc.
5125 Harvester Rd.
Unit 6
Burlington, Ont., Canada,  CA L7L 6A2
Applicant Contact ALLE CHAN
Correspondent
Pulse Scientific, Inc.
5125 Harvester Rd.
Unit 6
Burlington, Ont., Canada,  CA L7L 6A2
Correspondent Contact ALLE CHAN
Regulation Number866.5775
Classification Product Code
DHR  
Date Received07/28/1992
Decision Date 10/05/1992
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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