FDA 510(k) Applications for Medical Device Product Code "DBE"
(Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K800820 CALBIOCHEM-BEHRING CORP. AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY 04/24/1980
K800228 CLINICAL SCIENCES, INC. IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT 02/21/1980
K810983 IMMUNO-PRODUCTS INDUSTRIES ANTISMOOTH MUSCLE ANTIBODY TEST SYS 05/01/1981
K790430 MEDICA CORP. MEDICA II-F-ASMA TEST KIT 04/23/1979
K771155 MELOY LABORATORIES, INC. ANTI-MITOCHONDRIAL 08/04/1977
K760156 ZEUS SCIENTIFIC, INC. TEST, (IVDP) SMOOTHMUSCLE ANTIBODY 07/20/1976


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