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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K970220
Device Name IS-ANTI-SM TEST SYSTEM
Applicant
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Applicant Contact LYNNE STIRLING, PH.D.
Correspondent
Diamedix Corp.
2140 N. Miami Ave.
Miami,  FL  33127
Correspondent Contact LYNNE STIRLING, PH.D.
Regulation Number866.5100
Classification Product Code
LLL  
Date Received01/21/1997
Decision Date 04/08/1997
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
Recalls CDRH Recalls
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