Reference Diagnostics, Inc.
Medical device manufacturer in Bedford, MA.
17510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K053291 | Ferritin Calibrator Set, Catalog No. 8203JIT · Abbreviated | 03/13/2006SE |
| K053211 | Rdi Hsferritin KitDBF · Traditional | 03/13/2006SE |
| K052148 | Total Iron-Binding Capacity Calibrator Set. Direct Tibc Calibrator SetJIT · Abbreviated | 11/09/2005SE |
| K030044 | Extended Range HS CRP Kit, Cat NO:9200DCK · Traditional | 09/30/2003SE |
| K030772 | Rdi Extended Range CRP Calibrator SetJIT · Abbreviated | 04/11/2003SE |
| K021609 | Rdi HS CRP KitDCK · Traditional | 06/27/2002SE |
| K021607 | Rdi HS CRP Calibrator SetJIT · Abbreviated | 06/27/2002SE |
| K000783 | Direct Tibc CalibratorJIT · Abbreviated | 05/04/2000SE |
| K000781 | Direct Tibc KitJMO · Traditional | 05/02/2000SE |
| K990216 | Magnetic Tibc KitJMO · Traditional | 02/16/1999SE |
| K984107 | Rdi Direct LDL Cholesterol TestMRR · Traditional | 01/28/1999SE |
| K973988 | Rdi Homogeneous HDL Cholesterol TestLBS · Traditional | 12/22/1997SE |
| K964064 | Rdi Lipidirect Magnetic LDL ReagentMRR · Traditional | 11/20/1996SE |
| K964063 | Rdi LDL Precipitation ReagentMRR · Traditional | 11/20/1996SE |
| K944975 | Magnetic HDL Cholesterol TestLBR · Traditional | 08/02/1995SE |
| K911906 | Magnetic HDL Cholesterol TestLBR · Traditional | 07/18/1991SE |
| K893740 | Lipidirect Low Density Lipoprotein Cholesterol TesMRR · Traditional | 03/19/1990SE |