Mission Lipid Panel Monitoring System
FDA 510(k) K180504 · ACON Laboratories, Inc.
510(k) numberK180504
Submission
- Device name
- Mission Lipid Panel Monitoring System
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- February 26, 2018
- Decision date
- March 28, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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| K190490 | VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/27/2019SE |
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| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
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Questions and answers
When was Mission Lipid Panel Monitoring System cleared by the FDA?
Mission Lipid Panel Monitoring System (K180504) received a 510(k) decision of Substantially Equivalent on March 28, 2018, 30 days after the submission was received.
What is the product code of K180504?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.