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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antinuclear antibody, indirect immunofluorescent, antigen, control
510(k) Number K813592
Device Name QUANTAFLUOR FLUORESCENT TEST REAGENTS
Applicant
KALLESTAD LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KALLESTAD LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.5100
Classification Product Code
DHN  
Date Received12/28/1981
Decision Date 01/18/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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