FDA 510(k) Applications for Medical Device Product Code "LBT"
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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 |