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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 K974370
Device Name RAPET RF
Applicant
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Applicant Contact KIRK JOHNSON
Correspondent
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Correspondent Contact KIRK JOHNSON
Regulation Number866.5775
Classification Product Code
DHR  
Date Received11/20/1997
Decision Date 02/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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