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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 K911679
Device Name ANTI-JO-1 MICROASSAY
Applicant
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI,  FL  33127
Applicant Contact DAVID J KIEFER
Correspondent
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI,  FL  33127
Correspondent Contact DAVID J KIEFER
Regulation Number866.5100
Classification Product Code
LLL  
Date Received04/15/1991
Decision Date 09/23/1991
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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