Cholestech LDX System
FDA 510(k) K223179 · Alere San Diego, Inc.
510(k) numberK223179
Submission
- Device name
- Cholestech LDX System
- Applicant
- Alere San Diego, Inc.
San Diego, CA, US - Received
- October 11, 2022
- Decision date
- September 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252488 | ABL90 FLEX PLUS SystemCGA · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K210933 | YSI 2900C Biochemistry AnalyzerCGA · Traditional | Ysi, Inc. | 09/30/2024SE |
| K220328 | EasyStat 300CGA · Traditional | Medica Corporation | 07/26/2024SE |
| K223755 | i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 09/11/2023SE |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 07/28/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | Instrumentation Laboratory CO | 01/27/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 10/18/2022SE |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 08/13/2021SE |
| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 03/13/2020SE |
| K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
More from Abbott Point of Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151935 | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood…LYR · Special | 08/12/2015SE |
Questions and answers
When was Cholestech LDX System cleared by the FDA?
Cholestech LDX System (K223179) received a 510(k) decision of Substantially Equivalent on September 20, 2023, 344 days after the submission was received.
What is the product code of K223179?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.