i-STAT CHEM8+ cartridge with the i-STAT 1 System
FDA 510(k) K191298 · Abbott Point of Care, Inc.
510(k) numberK191298
Submission
- Device name
- i-STAT CHEM8+ cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc.
Princton, NJ, US - Received
- May 14, 2019
- Decision date
- February 7, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFL – Ph Rate Measurement, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040975 | Genchem CO2 Acid ReagentJFL · Traditional | Genchem, Inc. | 12/27/2004SE |
| K014034 | Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro)JFL · Special | Beckman Coulter, Inc. | 12/18/2001SE |
| K963541 | Sigma Diagnostics CO2 Acid ReagentJFL · Traditional | Sigma Diagnostics, Inc. | 10/24/1996SE |
| K963538 | Sigma Diagnostics CO2ALKALINE BufferJFL · Traditional | Sigma Diagnostics, Inc. | 10/11/1996SE |
| K963540 | Sigma Diagnostics Electrolyte BufferJFL · Traditional | Sigma Diagnostics, Inc. | 09/27/1996SE |
| K963005 | Nova 16 Analyzer (Modification Point of Care Usage)JFL · Traditional | Nova Biomedical Corp. | 08/23/1996SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | Sigma Chemical Co. | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | Sigma Chemical Co. | 12/17/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | Sigma Chemical Co. | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | Sigma Chemical Co. | 10/22/1993SE |
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|---|---|---|
| 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 (K191298) received a 510(k) decision of Substantially Equivalent on February 7, 2020, 269 days after the submission was received.
What is the product code of K191298?
The FDA product code is JFL – Ph Rate Measurement, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.