Fermcotest CO2 Reagnet
FDA 510(k) K822117 · Fermco Biochemics, Inc.
510(k) numberK822117
Submission
- Device name
- Fermcotest CO2 Reagnet
- Applicant
- Fermco Biochemics, Inc.
Mchenry, IL, US - Received
- July 19, 1982
- Decision date
- September 30, 1982
- 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 |
|---|---|---|
| K843832 | Triglycerides Reagent SystemCDT · Traditional | 11/27/1984SE |
| K823106 | Rermco Test Chloride ReagentJFS · Traditional | 11/16/1982SE |
| K822118 | Fermcotest Creatinine Test ReagentCGX · Traditional | 09/30/1982SE |
| K810567 | Germco Test R Glucose Test KitCGA · Traditional | 03/13/1981SE |
| K791066 | Glucose God-Pap Trinder Method Test KitCGA · Traditional | 09/04/1979SE |
| K791018 | Fermcotest R Bun Rate Reagent Test KitCDS · Traditional | 07/17/1979SE |
| K781945 | Glucose Oxidase ReagentCGA · Traditional | 01/17/1979SE |
Questions and answers
When was Fermcotest CO2 Reagnet cleared by the FDA?
Fermcotest CO2 Reagnet (K822117) received a 510(k) decision of Substantially Equivalent on September 30, 1982, 73 days after the submission was received.
What is the product code of K822117?
The FDA product code is JFL – Ph Rate Measurement, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.