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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 K972220
Device Name RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, CO. ANTRIM,  IE BT29 4QY
Applicant Contact P. ARMSTRONG
Correspondent
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, CO. ANTRIM,  IE BT29 4QY
Correspondent Contact P. ARMSTRONG
Regulation Number866.5775
Classification Product Code
DHR  
Date Received06/12/1997
Decision Date 09/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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