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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Ribosomal P Antibodies
510(k) Number K950169
Device Name RIBOSOMAL P EIA TEST SYSTEM
Applicant
Hogan & Hartson
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact EDWARD C WILSON, JR.
Correspondent
Hogan & Hartson
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact EDWARD C WILSON, JR.
Regulation Number866.5100
Classification Product Code
MQA  
Date Received01/17/1995
Decision Date 05/23/1996
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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