Rermco Test Chloride Reagent
FDA 510(k) K823106 · Fermco Biochemics, Inc.
510(k) numberK823106
Submission
- Device name
- Rermco Test Chloride Reagent
- Applicant
- Fermco Biochemics, Inc.
Mchenry, IL, US - Received
- October 21, 1982
- Decision date
- November 16, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFS – Coulometric, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121823 | Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer…JFS · Traditional | Wescor, Inc. | 03/27/2013SE |
| K923598 | Redi-Check Photmeter Q.A.JFS · Traditional | Awareness Technology, Inc. | 10/14/1992SE |
| K873127 | Chloride Reagent KitJFS · Traditional | A-Kem, Inc. | 10/23/1987SE |
| K830217 | Reagents Corning Chloride Meter forJFS · Traditional | Fisher Scientific Co., LLC | 02/18/1983SE |
| K820411 | Liquizyme Chloride ReagentJFS · Traditional | American Research Products Co. | 03/08/1982SE |
| K811319 | Chloride Reagent KitJFS · Traditional | Chem-Elec, Inc. | 08/13/1981SE |
| K811701 | Chloride/Carbon Dioxide Rate ReagentJFS · Traditional | Chem-Elec, Inc. | 07/01/1981SE |
| K810550 | Silver AnodeJFS · Traditional | Nobel Scientific Industries, Inc. | 04/08/1981SE |
| K810615 | Corning 925 Chloride MeterJFS · Traditional | Corning Medical & Scientific | 03/17/1981SE |
| K802080 | Baker Diag. Ultrarate Chloride KitJFS · Traditional | J.T. Baker Chemical Co. | 10/10/1980SE |
More from J.T. Baker Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K843832 | Triglycerides Reagent SystemCDT · Traditional | 11/27/1984SE |
| K822118 | Fermcotest Creatinine Test ReagentCGX · Traditional | 09/30/1982SE |
| K822117 | Fermcotest CO2 ReagnetJFL · 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 Rermco Test Chloride Reagent cleared by the FDA?
Rermco Test Chloride Reagent (K823106) received a 510(k) decision of Substantially Equivalent on November 16, 1982, 26 days after the submission was received.
What is the product code of K823106?
The FDA product code is JFS – Coulometric, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.