Replacement Parts Nova Electrolyte Anal
FDA 510(k) K842656 · Shaban Mfg. Co.
510(k) numberK842656
Submission
- Device name
- Replacement Parts Nova Electrolyte Anal
- Applicant
- Shaban Mfg. Co.
Mchenry, IL, US - Received
- July 10, 1984
- Decision date
- August 12, 1984
- 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 |
|---|---|---|
| K853621 | Replacement Pump TubingJJE · Traditional | 12/05/1985SE |
| K850333 | Pump Tube Sets for Hema-Tek I & II Slide StainersKPA · Traditional | 02/27/1985SE |
| K850157 | Cannulas for Hema-Tek I & KK Slide StainersKPA · Traditional | 02/27/1985SE |
| K844781 | Membrane KITS-KC1, CO2 & 02 for Instrument-LabCHL · Traditional | 02/01/1985SE |
| K844235 | Chloride StandardJIS · Traditional | 11/20/1984SE |
| K841610 | Components for Potassium, Sodium ChloJGT · Traditional | 05/25/1984SE |
| K841609 | Components for Partial Pressure EleeCHL · Traditional | 05/25/1984SE |
| K840557 | Reagents & Standards Il 501 Na/KJGS · Traditional | 04/04/1984SE |
| K840530 | Supplies for Instrumentation Lab FlameJJO · Traditional | 03/30/1984SE |
| K840468 | Partial Press. Electrode MeasurementCHL · Traditional | 03/30/1984SE |
Questions and answers
When was Replacement Parts Nova Electrolyte Anal cleared by the FDA?
Replacement Parts Nova Electrolyte Anal (K842656) received a 510(k) decision of Substantially Equivalent on August 12, 1984, 33 days after the submission was received.
What is the product code of K842656?
The FDA product code is JFL – Ph Rate Measurement, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.