Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
FDA 510(k) K163406 · ACON Laboratories, Inc.
510(k) numberK163406
Submission
- Device name
- Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- December 5, 2016
- Decision date
- July 11, 2017
- 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
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| 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 |
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Questions and answers
When was Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System cleared by the FDA?
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (K163406) received a 510(k) decision of Substantially Equivalent on July 11, 2017, 218 days after the submission was received.
What is the product code of K163406?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.