FDA 510(k) Applications for Medical Device Product Code "DAA"
(Igg, Peroxidase, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K831927 BREIT LABORATORIES, INC. ANTINUCLEAR ANTIBODY TEST KIT 07/18/1983
K832675 CLINICAL SCIENCES, INC. ANA MICROZYME TEST SYS #1610 09/12/1983
K822911 CLINICAL SCIENCES, INC. ANAZYME ANA PEROXIDASE TEST SYSTEM 10/22/1982
K791749 CLINICAL SCIENCES, INC. INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL 10/17/1979
K830005 DIAGNOSTIC REAGENT TECH. IP SPECIFIC G 06/02/1983


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