Magnetic HDL Cholesterol Test
FDA 510(k) K944975 · Reference Diagnostics, Inc.
510(k) numberK944975
Submission
- Device name
- Magnetic HDL Cholesterol Test
- Applicant
- Reference Diagnostics, Inc.
Bedford, MA, US - Received
- October 11, 1994
- Decision date
- August 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LBR – Ldl & Vldl Precipitation, Hdl
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LBR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143691 | LDLC3 LDL-Cholesterol Gen.3LBR · Traditional | Roche Diagnostics Operations (Rdo) | 01/28/2015SE |
| K072523 | Diazyme Ldl-Cholesterol Reagent, Calibrator and ControlsLBR · Traditional | General Atomics | 01/22/2008SE |
| K050823 | Direct HDL Cholesterol and Direct Hdl/Ldl CalibratorLBR · Traditional | Teco Diagnostics | 07/26/2005SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | Hemagen Diagnostics, Inc. | 12/24/2002SE |
| K012593 | Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent, Vitros Chemistry Products…LBR · Special | Ortho-Clinical Diagnostics, Inc. | 08/30/2001SE |
| K992029 | Atac Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | Elan Diagnostics | 08/12/1999SE |
| K992002 | Autohdl Cholesterol Reagent SetLBR · Traditional | Pointe Scientific, Inc., | 08/05/1999SE |
| K991789 | Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | Elan Holdings, Inc. | 07/09/1999SE |
| K990247 | MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470LBR · Traditional | Polymer Technology Systems, Inc. | 05/28/1999SE |
| K984303 | Vitros Chemistry Products Magnetic Hdl-Cholesterol ReagentLBR · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/28/1999SE |
More from Ortho-Clinical Diagnostics, Inc.
| 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 |
Questions and answers
When was Magnetic HDL Cholesterol Test cleared by the FDA?
Magnetic HDL Cholesterol Test (K944975) received a 510(k) decision of Substantially Equivalent on August 2, 1995, 295 days after the submission was received.
What is the product code of K944975?
The FDA product code is LBR – Ldl & Vldl Precipitation, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.