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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 (Enzyme-Labeled), Antigen, Control
510(k) Number K994424
Device Name DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
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
LRM  
Date Received12/30/1999
Decision Date 02/18/2000
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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