FDA 510(k) Applications for Medical Device Product Code "LHL"
(Reagents, Antibody, Legionella, Direct & Indirect Fluorescent)

FDA 510(k) Number Applicant Device Name Decision Date
K963318 ARMKEL, LLC. LEGIONELLA IGG/IGM ELISA TEST SYSTEM 03/03/1997
K970149 ZEUS SCIENTIFIC, INC. LEGIONELLA ELISA TEST SYSTEM 06/18/1997
K984123 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E 01/11/1999


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