Genchem CO2 Acid Reagent
FDA 510(k) K040975 · Genchem, Inc.
510(k) numberK040975
Submission
- Device name
- Genchem CO2 Acid Reagent
- Applicant
- Genchem, Inc.
Brea, CA, US - Received
- April 14, 2004
- Decision date
- December 27, 2004
- 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 |
|---|---|---|---|
| K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFL · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| 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 |
More from Sigma Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K090283 | Calibrator 1,2, and 3 Models: GEN-CAL1, GEN-CAL2, and GEN-CAL3JIX · Abbreviated | 06/05/2009SE |
| K040977 | Genchem Electrolyte BufferJGS · Traditional | 12/27/2004SE |
| K040976 | Genchem Creatinine ReagentCGX · Traditional | 12/27/2004SE |
| K040974 | Glucose Oxidase, GlucoseCGA · Traditional | 12/27/2004SE |
| K040973 | Bun ReagentCDS · Traditional | 12/27/2004SE |
| K040972 | Calcium, Azo Dye ReagentCJY · Traditional | 12/27/2004SE |
| K040971 | Genchem Ise Electrolyte ReferenceJGS · Traditional | 12/22/2004SE |
Questions and answers
When was Genchem CO2 Acid Reagent cleared by the FDA?
Genchem CO2 Acid Reagent (K040975) received a 510(k) decision of Substantially Equivalent on December 27, 2004, 257 days after the submission was received.
What is the product code of K040975?
The FDA product code is JFL – Ph Rate Measurement, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.