JFS — Coulometric, Chloride Class II
FDA product code JFS covers "Coulometric, Chloride", a Class II medical device regulated under 21 CFR 862.1170. Submissions are reviewed by the Clinical Chemistry panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JFS
- Device Class
- Class II
- Regulation Number
- 862.1170
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K121823 | wescor | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLOR | March 27, 2013 |
| K923598 | awareness technology | REDI-CHECK PHOTMETER Q.A. | October 14, 1992 |
| K873127 | a-kem | CHLORIDE REAGENT KIT | October 23, 1987 |
| K830217 | fisher scientific co | REAGENTS CORNING CHLORIDE METER FOR | February 18, 1983 |
| K823106 | fermco biochemics | RERMCO TEST CHLORIDE REAGENT | November 16, 1982 |
| K820411 | american research products | LIQUIZYME CHLORIDE REAGENT | March 8, 1982 |
| K811319 | chem-elec | CHLORIDE REAGENT KIT | August 13, 1981 |
| K811701 | chem-elec | CHLORIDE/CARBON DIOXIDE RATE REAGENT | July 1, 1981 |
| K810550 | nobel scientific industries | SILVER ANODE | April 8, 1981 |
| K810615 | corning medical and scientific | CORNING 925 CHLORIDE METER | March 17, 1981 |
| K802080 | j.t. baker chemical | BAKER DIAG. ULTRARATE CHLORIDE KIT | October 10, 1980 |
| K800585 | nobel scientific industries | NSI CHLORIDE REAGENT KIT | April 2, 1980 |
| K800217 | fisher scientific co | CHLORIDE REAGENT, CUP & CLEANER | February 26, 1980 |
| K791690 | hi chem | CHOLORDE REAGENT | September 17, 1979 |
| K790045 | j.t. baker chemical | REAGENT KIT, CHLORIDE/CARBON DIOXIDE | February 22, 1979 |
| K781275 | nobel scientific industries | CHLORIDE/CARBON DIOXIDE REAGENT SET | August 31, 1978 |
| K781132 | hi chem | CHEMLAR | August 10, 1978 |
| K771832 | gamma enterprises | CHLORIDE | November 22, 1977 |
| K760394 | bulcher instruments | REAGENT, CHLORIDOMETER ACID | November 1, 1976 |