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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 K970373
Device Name RAICHEM RHEUMATOID FACTOR SPIA
Applicant
Henage Diagnostics, Inc.
34-40 Bear Hill Rd.
Waltham,  MA  02154
Applicant Contact JOSEPH M CALLIFABO
Correspondent
Henage Diagnostics, Inc.
34-40 Bear Hill Rd.
Waltham,  MA  02154
Correspondent Contact JOSEPH M CALLIFABO
Regulation Number866.5775
Classification Product Code
DHR  
Date Received02/03/1997
Decision Date 04/17/1997
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
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