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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Rnp Antibody, Antigen And Control
510(k) Number K895338
Device Name ANTI-RNP AND ANTI-SM ANTIBODY TEST
Applicant
Immco Diagnostics, Inc.
963 Kenmore Ave.
Buffalo,  NY  14223
Applicant Contact RUSSELL NISENGARD
Correspondent
Immco Diagnostics, Inc.
963 Kenmore Ave.
Buffalo,  NY  14223
Correspondent Contact RUSSELL NISENGARD
Regulation Number866.5100
Classification Product Code
LKO  
Date Received08/31/1989
Decision Date 10/17/1989
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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