FDA 510(k) Applications for Medical Device Product Code "LIQ"
(Enzyme Linked Immunoabsorbent Assay, Rotavirus)

FDA 510(k) Number Applicant Device Name Decision Date
K972895 BIOMERIEUX VITEK, INC. VIDAS ROTAVIRUS (RTV) ASSAY 10/03/1997
K965092 BIOMERIEUX VITEK, INC. VIDAS ROTAVIRUS ASSAY 05/05/1997
K951208 ELDAN TECHNOLOGIES, LTD. ROTA-DAN RAPID ROTAVIRUS EIA KIT 02/14/1996
K971585 MERIDIAN DIAGNOSTICS, INC. IMMUNOCARD STAT! ROTAVIRUS 08/20/1997
K990842 SA SCIENTIFIC, INC. SAS ROTA TEST 08/09/1999
K964424 TRINITY BIOTECH, INC. ROTAVIRUS EIA 08/08/1997


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