i-STAT CHEM8+ cartridge with the i-STAT 1 System
FDA 510(k) K191360 · Abbott Point of Care, Inc.
510(k) numberK191360
Submission
- Device name
- i-STAT CHEM8+ cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc.
Princton, NJ, US - Received
- May 21, 2019
- Decision date
- February 14, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFP – Electrode, Ion Specific, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJFP · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer SystemJFP · Traditional | Nova Biomedical Corporation | 08/16/2019SE |
| K152327 | EasyLyte Na/K/Cl/Ca AnalyzerJFP · Traditional | Medica Corporation | 12/01/2016SE |
| K984299 | Avl Opti Critical Care AnalyzerJFP · Traditional | Avl Scientific Corp. | 12/11/1998SE |
| K972673 | Avl 9181 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 08/20/1997SE |
| K963694 | Easylyte Calcium/Chloride AnalyzerJFP · Traditional | Medica Corp. | 11/27/1996SE |
| K961458 | Avl 9180 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 06/12/1996SE |
| K960120 | Stat Profile Ultra F,G,H,I,J, and K AnalyzersJFP · Traditional | Nova Biomedical Corp. | 03/11/1996SE |
| K943091 | Easy Lyte Calcium AnalyzerJFP · Traditional | Medica Corp. | 01/17/1995SE |
| K943702 | Avl 988-4 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 09/09/1994SE |
More from Avl Scientific Corp.
| 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 CHEM8+ cartridge with the i-STAT 1 System cleared by the FDA?
i-STAT CHEM8+ cartridge with the i-STAT 1 System (K191360) received a 510(k) decision of Substantially Equivalent on February 14, 2020, 269 days after the submission was received.
What is the product code of K191360?
The FDA product code is JFP – Electrode, Ion Specific, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.