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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 K900241
Device Name ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY
Applicant
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI,  FL  33127
Applicant Contact KIEFER, PHD
Correspondent
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI,  FL  33127
Correspondent Contact KIEFER, PHD
Regulation Number866.5100
Classification Product Code
LLL  
Date Received01/17/1990
Decision Date 02/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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