Total Cholesterol Reagent
FDA 510(k) K890334 · Alpkem Corp.
510(k) numberK890334
Submission
- Device name
- Total Cholesterol Reagent
- Applicant
- Alpkem Corp.
Clackamas, OR, US - Received
- January 23, 1989
- Decision date
- May 3, 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 |
|---|---|---|
| K894011 | Total GalactoseKQP · Traditional | 01/11/1990SE |
| K891070 | Phenylalanine (Ninhydrin Reaction)JNB · Traditional | 10/27/1989SE |
| K890337 | Triglycerides - Gpo ReagentCDT · Traditional | 03/09/1989SE |
| K890336 | Glucose (God) ReagentCGA · Traditional | 02/27/1989SE |
| K890335 | Sodium Hydroxide Solution, Creatinine Reag./Dilu.CGE · Traditional | 02/17/1989SE |
| K890333 | Albumin ReagentEIX · Traditional | 02/17/1989SE |
| K890332 | RFA/2 Rapid Flow Analyzer W/ComputerJJC · Traditional | 02/17/1989SE |
| K883020 | RFA-300 Rapid Flow Analyzer W/ComputerJJF · Traditional | 09/02/1988SE |
| K860367 | Magnesium (Substrate, Enzyme, Reagent)JGF · Traditional | 04/11/1986SE |
| K852005 | MG ReagentJGJ · Traditional | 06/25/1985SE |
Questions and answers
When was Total Cholesterol Reagent cleared by the FDA?
Total Cholesterol Reagent (K890334) received a 510(k) decision of Substantially Equivalent on May 3, 1989, 100 days after the submission was received.
What is the product code of K890334?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.