Atac Pak Cholesterol Reagent and Atac Callibrator Kits
FDA 510(k) K000900 · Elan Holdings, Inc.
510(k) numberK000900
Submission
- Device name
- Atac Pak Cholesterol Reagent and Atac Callibrator Kits
- Applicant
- Elan Holdings, Inc.
Brea, CA, US - Received
- March 21, 2000
- Decision date
- May 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251091 | LipidsCHH · Traditional | Truvian Health | 12/30/2025SE |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESCHH · Traditional | Medicon Hellas S.A | 08/09/2024SE |
| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/27/2019SE |
| K181373 | Extended Lipid Panel AssayCHH · Traditional | Laboratory Corporation of America Holdings | 10/18/2018SE |
| K180504 | Mission Lipid Panel Monitoring SystemCHH · Special | ACON Laboratories, Inc. | 03/28/2018SE |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH · Traditional | ACON Laboratories, Inc. | 07/11/2017SE |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | Polymer Technology Systems, Inc. | 12/22/2016SE |
| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional | Axis-Shield Poc AS | 03/21/2014SE |
More from Axis-Shield Poc AS
| 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 |
| 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 |
| K991789 | Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | 07/09/1999SE |
Questions and answers
When was Atac Pak Cholesterol Reagent and Atac Callibrator Kits cleared by the FDA?
Atac Pak Cholesterol Reagent and Atac Callibrator Kits (K000900) received a 510(k) decision of Substantially Equivalent on May 2, 2000, 42 days after the submission was received.
What is the product code of K000900?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.