FDA product code JFS: Coulometric, Chloride
JFS is the FDA product code for coulometric, chloride. It is a Class II device, regulated under 21 CFR 862.1170 and reviewed by the Clinical Chemistry panel. FDA has cleared 19 510(k) submissions under JFS, from 13 different applicants. The average 510(k) review took 56 days (median 38). FDA has posted 2 recalls for JFS devices.
Classification
| Field | Value |
|---|---|
| Device name | Coulometric, Chloride |
| Device class | Class II |
| Regulation | 21 CFR 862.1170 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JFS clearance
Top JFS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nobel Scientific Industries, Inc. | 3 | 1981-04-08 |
| Fisher Scientific Co., LLC | 2 | 1983-02-18 |
| Chem-Elec, Inc. | 2 | 1981-08-13 |
| J.T. Baker Chemical Co. | 2 | 1980-10-10 |
| Hi Chem, Inc. | 2 | 1979-09-17 |
8 more applicants have JFS clearances. See the full list in Caduvo.
Most recent JFS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121823 | Wescor, Inc. | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC | 2013-03-27 | 279 |
| K923598 | Awareness Technology, Inc. | REDI-CHECK PHOTMETER Q.A. | 1992-10-14 | 86 |
| K873127 | A-Kem, Inc. | CHLORIDE REAGENT KIT | 1987-10-23 | 74 |
| K830217 | Fisher Scientific Co., LLC | REAGENTS CORNING CHLORIDE METER FOR | 1983-02-18 | 25 |
| K823106 | Fermco Biochemics, Inc. | RERMCO TEST CHLORIDE REAGENT | 1982-11-16 | 26 |
Recalls for JFS devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-09-02.
Frequently asked questions
What is FDA product code JFS?
JFS is the FDA product code for coulometric, chloride. It is a Class II device, regulated under 21 CFR 862.1170 and reviewed by the Clinical Chemistry panel.
What device class is JFS?
Class II, regulation 21 CFR 862.1170. Typical premarket route: 510(k).
How long does a 510(k) take for product code JFS?
Across 19 cleared submissions the average was 56 days from receipt to decision (median 38).
Which companies have the most JFS clearances?
Nobel Scientific Industries, Inc. (3); Fisher Scientific Co., LLC (2); Chem-Elec, Inc. (2); J.T. Baker Chemical Co. (2); Hi Chem, Inc. (2).
Have JFS devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2016-09-02.
Next steps
- Run an FDA pathway report with predicate devices for product code JFS
- Run a recall and safety report across every JFS manufacturer
- Watch product code JFS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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