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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 K970237
Device Name IS-ANTI-SSB TEST SYSTEM (720-260)
Applicant
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI,  FL  33127
Applicant Contact LYNNE STIRLING
Correspondent
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI,  FL  33127
Correspondent Contact LYNNE STIRLING
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
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