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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody, Antigen And Control
510(k) Number K921658
Device Name ANTI-DSDNA ANTIBODY TEST
Applicant
Immco Diagnostics, Inc.
963 Kenmore Ave.
Buffalo,  NY  14223
Applicant Contact SUSAN KRASNY
Correspondent
Immco Diagnostics, Inc.
963 Kenmore Ave.
Buffalo,  NY  14223
Correspondent Contact SUSAN KRASNY
Regulation Number866.5100
Classification Product Code
LSW  
Date Received04/07/1992
Decision Date 03/22/1993
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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