HDL Cholesterol Kit
FDA 510(k) K881244 · Trace Scientific , Ltd.
510(k) numberK881244
Submission
- Device name
- HDL Cholesterol Kit
- Applicant
- Trace Scientific , Ltd.
Clayton, Vic 3168, AU - Received
- March 23, 1988
- Decision date
- June 10, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K982121 | Enzymatic Mitochondrial Antibody (M2) ReagentDBM · Traditional | 09/17/1998SE |
| K981123 | UreaCDQ · Traditional | 04/24/1998SE |
| K962890 | Cholesterol-Incorporating Dynamic Stab Tech (DST)CHH · Traditional | 09/27/1996SE |
| K961114 | Ast Incorporating DSTCIT · Traditional | 05/23/1996SE |
| K961123 | Alt Incorporating DSTCKA · Traditional | 04/25/1996SE |
| K952488 | Trace Cobas Mira RangeCIX · Traditional | 10/13/1995SE |
| K932713 | Trace Transferrin ReagentDDQ · Traditional | 09/30/1993SE |
| K923322 | Trace Albumin-Mr ReagentCIX · Traditional | 09/11/1992SE |
| K914731 | Trace Gamma Gt-Ss ReagentJQB · Traditional | 11/19/1991SE |
| K911866 | Trace Total/Direct Bilirubin ReagentCIG · Traditional | 07/17/1991SE |
Questions and answers
When was HDL Cholesterol Kit cleared by the FDA?
HDL Cholesterol Kit (K881244) received a 510(k) decision of Substantially Equivalent on June 10, 1988, 79 days after the submission was received.
What is the product code of K881244?
The FDA product code is LBR – Ldl & Vldl Precipitation, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.