Colorimetric Method, Lipoproteins
FDA product code JHM · Class I (low risk) · 21 CFR 862.1475 · Clinical Chemistry
9510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120662 | Piccolo Hdl-Capillary Test SystemJHM · Traditional | Abaxis, Inc. | 04/24/2012SE |
| K081300 | Dimension Vista HDLC Flex Reagent CartridgeJHM · Special | Siemens Healthcare Diagnostics | 07/02/2008SE |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional | Dade Behring, Inc. | 02/21/2008SE |
| K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48AJHM · Traditional | Dade Behring, Inc. | 10/30/2003SE |
| K022519 | LDL Cholesterol (Automated)JHM · Traditional | Jas Diagnostics, Inc. | 09/30/2002SE |
| K983849 | Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent CartridgeJHM · Traditional | Dade Behring, Inc. | 01/11/1999SE |
| K902935 | Roche Cobas Ready HDL Cholesterol ReagentJHM · Traditional | Roche Diagnostic Systems, Inc. | 09/27/1990SE |
| K841056 | HDL Precipitant Reagent SetJHM · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K780173 | Lypoprotein Cholesterol Test KitJHM · Traditional | Environmental Chemical Specialties | 05/03/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0089-2023 Class II | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD…Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or… | Siemens Healthcare Diagnostics, Inc. | 08/24/2022Open, Classified |
| Z-1188-2021 Class II | Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid…Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored… | Siemens Healthcare Diagnostics, Inc. | 02/03/2021Open, Classified |
| Z-1663-2016 Class II | Dimension Vista Assays: Direct HDL Cholesterol (AHDL)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | Siemens Healthcare Diagnostics, Inc. | 03/17/2016Terminated |
| Z-1659-2016 Class II | Dimension Assays: Direct HDL Cholesterol (AHDL)Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | Siemens Healthcare Diagnostics, Inc. | 03/17/2016Terminated |