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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 K920753
Device Name RF STAT IGM TEST KIT
Applicant
Biowhittaker Molecular Applications, Inc.
8830 Biggs Ford Rd.
Walkersville,  MD  21793
Applicant Contact LEIF E OLSEN
Correspondent
Biowhittaker Molecular Applications, Inc.
8830 Biggs Ford Rd.
Walkersville,  MD  21793
Correspondent Contact LEIF E OLSEN
Regulation Number866.5775
Classification Product Code
DHR  
Date Received02/19/1992
Decision Date 03/30/1992
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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