i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k) K223710 · Abbott Point of Care, Inc.
510(k) numberK223710
Submission
- Device name
- i-STAT CG8+ cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc.
Princton, NJ, US - Received
- December 12, 2022
- Decision date
- July 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| 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 |
| K223179 | Cholestech LDX SystemCGA · Dual Track | Alere San Diego, Inc. | 09/20/2023SE |
| K223755 | i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 09/11/2023SE |
| 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 |
|---|---|---|
| K261039 | i-STAT Crea cartridge with the i-STAT 1 SystemCGL · Traditional | 06/26/2026SE |
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMI · Traditional | 06/11/2026SE |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL · Traditional | 05/02/2025SE |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI · Traditional | 01/03/2025SE |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity SystemQAT · Traditional | 03/27/2024SE |
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJFP · Traditional | 10/27/2023SE |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL · Traditional | 10/27/2023SE |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | 10/27/2023SE |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 SystemCHL · Traditional | 09/15/2023SE |
| K223755 | i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional | 09/11/2023SE |
Questions and answers
When was i-STAT CG8+ cartridge with the i-STAT 1 System cleared by the FDA?
i-STAT CG8+ cartridge with the i-STAT 1 System (K223710) received a 510(k) decision of Substantially Equivalent on July 28, 2023, 228 days after the submission was received.
What is the product code of K223710?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.