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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 K851099
Device Name IGM RHEUMATOID FACTOR TEST KIT
Applicant
Breit Laboratories, Inc.
2510 Boatman Ave.
West Sacramento,  CA  95691
Applicant Contact LEROY L KONDO
Correspondent
Breit Laboratories, Inc.
2510 Boatman Ave.
West Sacramento,  CA  95691
Correspondent Contact LEROY L KONDO
Regulation Number866.5775
Classification Product Code
DHR  
Date Received03/19/1985
Decision Date 04/25/1985
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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