Nsi Carbon Dioxide Reagent Kit
FDA 510(k) K800586 · Nobel Scientific Industries, Inc.
510(k) numberK800586
Submission
- Device name
- Nsi Carbon Dioxide Reagent Kit
- Applicant
- Nobel Scientific Industries, Inc.
Mchenry, IL, US - Received
- March 17, 1980
- Decision date
- April 4, 1980
- 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 |
|---|---|---|
| K854717 | Nsi Astra TM Total Protein Reagent Kit, Nsi #7928CEK · Traditional | 01/14/1986SE |
| K854716 | Nsi Astra TM Calcium Reagent Kit Nsi Item # 7909CIC · Traditional | 01/07/1986SE |
| K854718 | Nsi Astra TM Albumin Reagent Kit Nsi Item # 7926CIX · Traditional | 12/19/1985SE |
| K850944 | Nsi Lysing-D Reagent -4000 MLGGK · Traditional | 03/29/1985SE |
| K844782 | Nsi Elt-D Diluting Fluid 4000MLGIF · Traditional | 03/05/1985SE |
| K823283 | Flushing Solution · Traditional | 12/03/1982SE |
| K812866 | Astra Reagent Concentrate SystemCGA · Traditional | 12/17/1981SE |
| K810550 | Silver AnodeJFS · Traditional | 04/08/1981SE |
| K810549 | Thermal Printer PaperJJE · Traditional | 04/08/1981SE |
| K802518 | Bun Reagent Astra 4 & 8 AnalyzersCDN · Traditional | 11/12/1980SE |
Questions and answers
When was Nsi Carbon Dioxide Reagent Kit cleared by the FDA?
Nsi Carbon Dioxide Reagent Kit (K800586) received a 510(k) decision of Substantially Equivalent on April 4, 1980, 18 days after the submission was received.
What is the product code of K800586?
The FDA product code is JFL – Ph Rate Measurement, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.