Carbon Dioxide Reagent Kit
FDA 510(k) K873129 · A-Kem, Inc.
510(k) numberK873129
Submission
- Device name
- Carbon Dioxide Reagent Kit
- Applicant
- A-Kem, Inc.
Clifton, NJ, US - Received
- August 10, 1987
- Decision date
- October 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFL · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| 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 |
More from Sigma Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K884224 | Total Bilirubin Reagent Kit for Astra SystemsCIG · Traditional | 12/15/1988SE |
| K884227 | Calibrator Standard Kit for Astra SystemJIX · Traditional | 12/09/1988SE |
| K884226 | Amylase Reagent Kit for Astra SystemsCJA · Traditional | 12/09/1988SE |
| K884225 | Total Protein Reagent Kit for Astra SystemsCEK · Traditional | 12/09/1988SE |
| K882587 | A-Kem Albumin Reagent Kit for Astra SystemCIX · Traditional | 08/08/1988SE |
| K882586 | A-Kem Calcium Reagent Kit for Astra SystemCIC · Traditional | 08/08/1988SE |
| K873132 | Bun Reagent KitLFP · Traditional | 10/23/1987SE |
| K873131 | Creatinine Reagent KitCGX · Traditional | 10/23/1987SE |
| K873130 | Wash Solution KitJJE · Traditional | 10/23/1987SE |
| K873128 | Glucose Reagent KitCGA · Traditional | 10/23/1987SE |
Questions and answers
When was Carbon Dioxide Reagent Kit cleared by the FDA?
Carbon Dioxide Reagent Kit (K873129) received a 510(k) decision of Substantially Equivalent on October 23, 1987, 74 days after the submission was received.
What is the product code of K873129?
The FDA product code is JFL – Ph Rate Measurement, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.