JFS · Coulometric, Chloride
Clinical Chemistry · 21 CFR 862.1170 · Class 2
Overview
| Product Code | JFS |
|---|---|
| Device Name | Coulometric, Chloride |
| Regulation | 21 CFR 862.1170 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Classification Rationale
Class II.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC | Wescor, Inc. | Mar 27, 2013 | SESE |
| K923598 | REDI-CHECK PHOTMETER Q.A. | Awareness Technology, Inc. | Oct 14, 1992 | SESE |
| K873127 | CHLORIDE REAGENT KIT | A-Kem, Inc. | Oct 23, 1987 | SESE |
| K830217 | REAGENTS CORNING CHLORIDE METER FOR | Fisher Scientific Co., LLC | Feb 18, 1983 | SESE |
| K823106 | RERMCO TEST CHLORIDE REAGENT | Fermco Biochemics, Inc. | Nov 16, 1982 | SESE |
| K820411 | LIQUIZYME CHLORIDE REAGENT | American Research Products Co. | Mar 8, 1982 | SESE |
| K811319 | CHLORIDE REAGENT KIT | Chem-Elec, Inc. | Aug 13, 1981 | SESE |
| K811701 | CHLORIDE/CARBON DIOXIDE RATE REAGENT | Chem-Elec, Inc. | Jul 1, 1981 | SESE |
| K810550 | SILVER ANODE | Nobel Scientific Industries, Inc. | Apr 8, 1981 | SESE |
| K810615 | CORNING 925 CHLORIDE METER | Corning Medical & Scientific | Mar 17, 1981 | SESE |
| K802080 | BAKER DIAG. ULTRARATE CHLORIDE KIT | J.T. Baker Chemical Co. | Oct 10, 1980 | SESE |
| K800585 | NSI CHLORIDE REAGENT KIT | Nobel Scientific Industries, Inc. | Apr 2, 1980 | SESE |
| K800217 | CHLORIDE REAGENT, CUP & CLEANER | Fisher Scientific Co., LLC | Feb 26, 1980 | SESE |
| K791690 | CHOLORDE REAGENT | Hi Chem, Inc. | Sep 17, 1979 | SESE |
| K790045 | REAGENT KIT, CHLORIDE/CARBON DIOXIDE | J.T. Baker Chemical Co. | Feb 22, 1979 | SESE |
| K781275 | CHLORIDE/CARBON DIOXIDE REAGENT SET | Nobel Scientific Industries, Inc. | Aug 31, 1978 | SESE |
| K781132 | CHEMLAR | Hi Chem, Inc. | Aug 10, 1978 | SESE |
| K771832 | CHLORIDE | Gamma Enterprises, Inc. | Nov 22, 1977 | SESE |
| K760394 | REAGENT, CHLORIDOMETER ACID | Bulcher Instruments | Nov 1, 1976 | SESE |
Top Applicants
- Nobel Scientific Industries, Inc. — 3 clearances
- Chem-Elec, Inc. — 2 clearances
- Fisher Scientific Co., LLC — 2 clearances
- Hi Chem, Inc. — 2 clearances
- J.T. Baker Chemical Co. — 2 clearances
