Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator Kits
FDA 510(k) K991789 · Elan Holdings, Inc.
510(k) numberK991789
Submission
- Device name
- Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator Kits
- Applicant
- Elan Holdings, Inc.
Brea, CA, US - Received
- May 25, 1999
- Decision date
- July 9, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K980772 | Hdl-Cholesterol Precipitating Reagent, Catalogue Number 205-51LBR · Traditional | Diagnostic Chemicals , Ltd. | 04/27/1998SE |
More from Diagnostic Chemicals , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K013152 | Atac Pak Direct HDL Reagent and Atac Direct HDL Calibrator KitsLBS · Traditional | 11/09/2001SE |
| K012474 | Atac Pak CPK Reagent KitCGS · Traditional | 10/03/2001SE |
| K010488 | Atac Pak Ast Reagent KitCIT · Traditional | 04/09/2001SE |
| K000958 | Atac Pak Bun Reagent and Atac Calibrator KitsCDQ · Traditional | 05/24/2000SE |
| K000900 | Atac Pak Cholesterol Reagent and Atac Callibrator KitsCHH · Traditional | 05/02/2000SE |
| K992844 | Hichem Ise Electrolyte BufferJGS · Traditional | 11/26/1999SE |
| K992842 | Hichem Ise Electrolyte ReferenceJGS · Traditional | 11/26/1999SE |
| K992846 | Hichem Total Protein ReagentCEK · Traditional | 10/18/1999SE |
| K992845 | Hichem Calibrator 1 Kit, Hichem Calibrator 2 Kit, Hichem Calibrator 3 Kit, Calibration…JIX · Traditional | 10/18/1999SE |
| K992847 | Hichem Bun ReagentLFP · Traditional | 10/14/1999SE |
Questions and answers
When was Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator Kits cleared by the FDA?
Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator Kits (K991789) received a 510(k) decision of Substantially Equivalent on July 9, 1999, 45 days after the submission was received.
What is the product code of K991789?
The FDA product code is LBR – Ldl & Vldl Precipitation, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.