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FDA 510(k) K113610, ANA-SCREEN WITH MDSS, by Bio-Rad Laboratories

FDA 510(k) K113610, ANA-SCREEN WITH MDSS, by Bio-Rad Laboratories

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510(K) Number: K113610
Device Name: ANA-SCREEN WITH MDSS
Manufacturer: Bio-Rad Laboratories
Device Classification Name: antinuclear antibody, antigen, control
Regulation Number: 866.5100
Classification Product Code: LKJ
Date Received: 12/06/2011
Decision Date: 07/09/2012
Regulation Medical Specialty: Immunology
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