Coulometric, Chloride
FDA product code JFS · Class II (moderate risk) · 21 CFR 862.1170 · Clinical Chemistry
19510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Nobel Scientific Industries, Inc. 3
- Hi Chem, Inc. 2
- J.T. Baker Chemical Co. 2
- Fisher Scientific Co., LLC 2
- Chem-Elec, Inc. 2
- Bulcher Instruments 1
- Gamma Enterprises, Inc. 1
- Corning Medical & Scientific 1
- American Research Products Co. 1
- Fermco Biochemics, Inc. 1
- A-Kem, Inc. 1
- Awareness Technology, Inc. 1
- Wescor, Inc. 1
510(k) clearances
| 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 |
| 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 |
| K800585 | Nsi Chloride Reagent KitJFS · Traditional | Nobel Scientific Industries, Inc. | 04/02/1980SE |
| K800217 | Chloride Reagent, Cup & CleanerJFS · Traditional | Fisher Scientific Co., LLC | 02/26/1980SE |
| K791690 | Cholorde ReagentJFS · Traditional | Hi Chem, Inc. | 09/17/1979SE |
| K790045 | Reagent Kit, Chloride/Carbon DioxideJFS · Traditional | J.T. Baker Chemical Co. | 02/22/1979SE |
| K781275 | Chloride/Carbon Dioxide Reagent SetJFS · Traditional | Nobel Scientific Industries, Inc. | 08/31/1978SE |
| K781132 | ChemlarJFS · Traditional | Hi Chem, Inc. | 08/10/1978SE |
| K771832 | ChlorideJFS · Traditional | Gamma Enterprises, Inc. | 11/22/1977SE |
| K760394 | Reagent, Chloridometer AcidJFS · Traditional | Bulcher Instruments | 11/01/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2913-2016 Class III | Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322…Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405… | Siemens Healthcare Diagnostics Inc | 09/02/2016Terminated |
| Z-2912-2016 Class III | Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405… | Siemens Healthcare Diagnostics Inc | 09/02/2016Terminated |