Enzymatic Cholesterol
FDA 510(k) K771820 · Macomb Chemical Co.
510(k) numberK771820
Submission
- Device name
- Enzymatic Cholesterol
- Applicant
- Macomb Chemical Co.
Mchenry, IL, US - Received
- September 23, 1977
- Decision date
- October 19, 1977
- 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 |
|---|---|---|
| K830095 | Rapid Chem Analyzer IIJJF · Traditional | 01/28/1983SE |
| K823720 | SpectrophotometerJJQ · Traditional | 01/07/1983SE |
| K810958 | GlycohemoglobinLCP · Traditional | 09/16/1981SE |
| K801086 | P-Nitrophenyl Phosphate · Traditional | 05/28/1980SE |
| K800719 | Enzymatic Urea Nitrogen Reagent Set ReviCDQ · Traditional | 05/08/1980SE |
| K800720 | Macomb Nad-Nicotinamide Adenine Dinucleo · Traditional | 04/21/1980SE |
| K792533 | Creatine Phosphokinase (CPK) Reagent SetJHW · Traditional | 01/11/1980SE |
| K792532 | Glucose (Hexokinase) Reagent SetCFR · Traditional | 01/11/1980SE |
| K791669 | Glucose Oxidase Reagent SetCGA · Traditional | 09/24/1979SE |
| K791511 | Enzymatic Reagent Set, 4X250 Ml.CHH · Traditional | 09/04/1979SE |
Questions and answers
When was Enzymatic Cholesterol cleared by the FDA?
Enzymatic Cholesterol (K771820) received a 510(k) decision of Substantially Equivalent on October 19, 1977, 26 days after the submission was received.
What is the product code of K771820?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.