Product code JFS
- Device name
- Coulometric, Chloride
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1170
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC | Wescor, Inc. | 2013-03-27 |
| K923598 | REDI-CHECK PHOTMETER Q.A. | Awareness Technology, Inc. | 1992-10-14 |
| K873127 | CHLORIDE REAGENT KIT | A-Kem, Inc. | 1987-10-23 |
| K830217 | REAGENTS CORNING CHLORIDE METER FOR | Fisher Scientific Co., LLC | 1983-02-18 |
| K823106 | RERMCO TEST CHLORIDE REAGENT | Fermco Biochemics, Inc. | 1982-11-16 |
| K820411 | LIQUIZYME CHLORIDE REAGENT | American Research Products Co. | 1982-03-08 |
| K811319 | CHLORIDE REAGENT KIT | Chem-Elec, Inc. | 1981-08-13 |
| K811701 | CHLORIDE/CARBON DIOXIDE RATE REAGENT | Chem-Elec, Inc. | 1981-07-01 |
| K810550 | SILVER ANODE | Nobel Scientific Industries, Inc. | 1981-04-08 |
| K810615 | CORNING 925 CHLORIDE METER | Corning Medical & Scientific | 1981-03-17 |
| K802080 | BAKER DIAG. ULTRARATE CHLORIDE KIT | J.T. Baker Chemical Co. | 1980-10-10 |
| K800585 | NSI CHLORIDE REAGENT KIT | Nobel Scientific Industries, Inc. | 1980-04-02 |
| K800217 | CHLORIDE REAGENT, CUP & CLEANER | Fisher Scientific Co., LLC | 1980-02-26 |
| K791690 | CHOLORDE REAGENT | Hi Chem, Inc. | 1979-09-17 |
| K790045 | REAGENT KIT, CHLORIDE/CARBON DIOXIDE | J.T. Baker Chemical Co. | 1979-02-22 |
| K781275 | CHLORIDE/CARBON DIOXIDE REAGENT SET | Nobel Scientific Industries, Inc. | 1978-08-31 |
| K781132 | CHEMLAR | Hi Chem, Inc. | 1978-08-10 |
| K771832 | CHLORIDE | Gamma Enterprises, Inc. | 1977-11-22 |
| K760394 | REAGENT, CHLORIDOMETER ACID | Bulcher Instruments | 1976-11-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03661540304095 | ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS | ELITECHGROUP INC. | 2021-02-19 |
| 03661540304088 | ChloroChek® Chloridometer® Sweat Chloride Analyzer | ELITECHGROUP INC. | 2016-09-24 |
| 00850229007119 | Redi-Check Photometer QC | AWARENESS TECHNOLOGY, INCORPORATED | 2016-06-30 |