Chloride/Carbon Dioxide Rate Reagent
FDA 510(k) K811701 · Chem-Elec, Inc.
510(k) numberK811701
Submission
- Device name
- Chloride/Carbon Dioxide Rate Reagent
- Applicant
- Chem-Elec, Inc.
Mchenry, IL, US - Received
- June 16, 1981
- Decision date
- July 1, 1981
- 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 |
| K823106 | Rermco Test Chloride ReagentJFS · Traditional | Fermco Biochemics, Inc. | 11/16/1982SE |
| K820411 | Liquizyme Chloride ReagentJFS · Traditional | American Research Products Co. | 03/08/1982SE |
| K811319 | Chloride Reagent KitJFS · Traditional | Chem-Elec, Inc. | 08/13/1981SE |
| 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 |
|---|---|---|
| K943503 | Chemcard Glucose TestCGA · Traditional | 07/23/1996SE |
| K864159 | Solid Phase Deter Serum Cholesterol FR Whole BloodCHH · Traditional | 06/10/1988SE |
| K811406 | Creatinine Rate Reagent KitCGX · Traditional | 08/13/1981SE |
| K811381 | AstraJFL · Traditional | 08/13/1981SE |
| K811319 | Chloride Reagent KitJFS · Traditional | 08/13/1981SE |
| K811165 | Glucose Oxidase Rate ReagentCGA · Traditional | 08/13/1981SE |
| K811310 | Sodium/Potassium Reagent KitsCEM · Traditional | 07/10/1981SE |
| K811193 | Bun Rate ReagentCDS · Traditional | 07/10/1981SE |
Questions and answers
When was Chloride/Carbon Dioxide Rate Reagent cleared by the FDA?
Chloride/Carbon Dioxide Rate Reagent (K811701) received a 510(k) decision of Substantially Equivalent on July 1, 1981, 15 days after the submission was received.
What is the product code of K811701?
The FDA product code is JFS – Coulometric, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.