Submission Details
| 510(k) Number | K180504 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 2018 |
| Decision Date | March 28, 2018 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Special
Mission Lipid Panel Monitoring System
Mar 2018
Decision
30d
Days
Class 1
Risk
About This 510(k) Submission
K180504 is an FDA 510(k) clearance for the Mission Lipid Panel Monitoring System, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on March 28, 2018, 30 days after receiving the submission on February 26, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.
Device Classification
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1175 |
Manufacturer
Similar Devices — CHH Enzymatic Esterase--oxidase, Cholesterol
All 229
K251091 · Truvian Health
· Dec 2025
K232404 · Medicon Hellas S.A
· Aug 2024
K203597 · Abbott Ireland Diagnostics Division
· Jun 2022
K190490 · Ortho-Clinical Diagnostics, Inc.
· Mar 2019
K181373 · Laboratory Corporation of America Holdings
· Oct 2018
K163406 · ACON Laboratories, Inc.
· Jul 2017
More from ACON Laboratories, Inc.
View all
K251697
· GTY · Nov 2025
K251749
· SCA · Oct 2025
K250085
· NBW · Oct 2025
K250377
· SCA · May 2025
K232715
· LCX · May 2024