Cla 200 Chempro(R) Lipid Analyzer
FDA 510(k) K892238 · Johnson & Johnson Professionals, Inc.
510(k) numberK892238
Submission
- Device name
- Cla 200 Chempro(R) Lipid Analyzer
- Applicant
- Johnson & Johnson Professionals, Inc.
Roseville, MN, US - Received
- April 4, 1989
- Decision date
- June 7, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K992173 | Siphonguard CSF Control DeviceJXG · Traditional | 04/07/2000SE |
| K991413 | Codman Ethisorb Dura PatchGXQ · Traditional | 03/13/2000SE |
| K991222 | Codman Microsensor Ventricular Catheter KitGWM · Traditional | 07/09/1999SE |
| K982379 | Sundt Slim-Line Aneurysm Clip ApplierHCI · Traditional | 12/18/1998SE |
| K982812 | G2 Total Hip System Femoral Stem (11/13 Taper)KWY · Traditional | 12/04/1998SE |
| K983141 | Capitello-Condylar Total Elbow ProsthesisJDB · Traditional | 11/06/1998SE |
| K983014 | Summit Acetabular SystemLPH · Traditional | 10/27/1998SE |
| K980778 | Hakim Micro Programmable Valve SystemJXG · Traditional | 07/17/1998SE |
| K974739 | Hakim Programmable Valve SystemJXG · Traditional | 07/01/1998SE |
| K980801 | J-Fx Bipolar HeadKWY · Traditional | 05/29/1998SE |
Questions and answers
When was Cla 200 Chempro(R) Lipid Analyzer cleared by the FDA?
Cla 200 Chempro(R) Lipid Analyzer (K892238) received a 510(k) decision of Substantially Equivalent on June 7, 1989, 64 days after the submission was received.
What is the product code of K892238?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.