FDA 510(k) Applications for Medical Device Product Code "LBT"
(Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl)

FDA 510(k) Number Applicant Device Name Decision Date
K972015 MORAX HYDRAGEL 7,15,30, CHOL-HDL KIT 10/27/1997
K990250 MORAX HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 06/18/1999
K000568 ROCHE DIAGNOSTICS CORP. HDL CHOLESTEROL PLUS 08/04/2000


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