Coulometric, Chloride
Coulometric Chloride measurement is a clinical chemistry test system that uses coulometric titration to precisely quantify chloride ion concentration in blood, serum, or other specimens, supporting assessment of acid-base balance and electrolyte disorders. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is JFS, regulated under 21 CFR 862.1170, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JFS
- Device Class
- FDA class 2
- Regulation Number
- 862.1170
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC | Mar 27, 2013 | Substantially Equivalent | Wescor, Inc. |
| K923598 | REDI-CHECK PHOTMETER Q.A. | Oct 14, 1992 | Substantially Equivalent | Awareness Technology, Inc. |
| K873127 | CHLORIDE REAGENT KIT | Oct 23, 1987 | Substantially Equivalent | A-Kem, Inc. |
| K830217 | REAGENTS CORNING CHLORIDE METER FOR | Feb 18, 1983 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K823106 | RERMCO TEST CHLORIDE REAGENT | Nov 16, 1982 | Substantially Equivalent | Fermco Biochemics, Inc. |
| K820411 | LIQUIZYME CHLORIDE REAGENT | Mar 08, 1982 | Substantially Equivalent | American Research Products Co. |
| K811319 | CHLORIDE REAGENT KIT | Aug 13, 1981 | Substantially Equivalent | Chem-Elec, Inc. |
| K811701 | CHLORIDE/CARBON DIOXIDE RATE REAGENT | Jul 01, 1981 | Substantially Equivalent | Chem-Elec, Inc. |
| K810550 | SILVER ANODE | Apr 08, 1981 | Substantially Equivalent | Nobel Scientific Industries, Inc. |
| K810615 | CORNING 925 CHLORIDE METER | Mar 17, 1981 | Substantially Equivalent | Corning Medical & Scientific |
| K802080 | BAKER DIAG. ULTRARATE CHLORIDE KIT | Oct 10, 1980 | Substantially Equivalent | J.T. Baker Chemical Co. |
| K800585 | NSI CHLORIDE REAGENT KIT | Apr 02, 1980 | Substantially Equivalent | Nobel Scientific Industries, Inc. |
| K800217 | CHLORIDE REAGENT, CUP & CLEANER | Feb 26, 1980 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K791690 | CHOLORDE REAGENT | Sep 17, 1979 | Substantially Equivalent | Hi Chem, Inc. |
| K790045 | REAGENT KIT, CHLORIDE/CARBON DIOXIDE | Feb 22, 1979 | Substantially Equivalent | J.T. Baker Chemical Co. |
| K781275 | CHLORIDE/CARBON DIOXIDE REAGENT SET | Aug 31, 1978 | Substantially Equivalent | Nobel Scientific Industries, Inc. |
| K781132 | CHEMLAR | Aug 10, 1978 | Substantially Equivalent | Hi Chem, Inc. |
| K771832 | CHLORIDE | Nov 22, 1977 | Substantially Equivalent | Gamma Enterprises, Inc. |
| K760394 | REAGENT, CHLORIDOMETER ACID | Nov 01, 1976 | Substantially Equivalent | Bulcher Instruments |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.