FDA product code JFL: Ph Rate Measurement, Carbon-Dioxide
JFL is the FDA product code for ph rate measurement, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel. FDA has cleared 28 510(k) submissions under JFL, from 19 different applicants. The average 510(k) review took 78 days (median 55). FDA has posted 3 recalls for JFL devices.
Classification
| Field | Value |
|---|---|
| Device name | Ph Rate Measurement, Carbon-Dioxide |
| Device class | Class II |
| Regulation | 21 CFR 862.1160 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JFL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 269 |
Compare with all 510(k) review times · Search every JFL clearance
Top JFL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 4 | 1994-01-03 |
| Sigma Diagnostics, Inc. | 3 | 1996-10-24 |
| Nova Biomedical Corp. | 2 | 1996-08-23 |
| Hichem Diagnostics | 2 | 1993-02-12 |
| American Research Products Co. | 2 | 1990-03-01 |
14 more applicants have JFL clearances. See the full list in Caduvo.
Most recent JFL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191298 | Abbott Point of Care, Inc. | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 2020-02-07 | 269 |
| K040975 | Genchem, Inc. | GENCHEM CO2 ACID REAGENT | 2004-12-27 | 257 |
| K014034 | Beckman Coulter, Inc. | MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) | 2001-12-18 | 11 |
| K963541 | Sigma Diagnostics, Inc. | SIGMA DIAGNOSTICS CO2 ACID REAGENT | 1996-10-24 | 50 |
| K963538 | Sigma Diagnostics, Inc. | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER | 1996-10-11 | 37 |
Recalls for JFL devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-01-29.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code JFL?
JFL is the FDA product code for ph rate measurement, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel.
What device class is JFL?
Class II, regulation 21 CFR 862.1160. Typical premarket route: 510(k).
How long does a 510(k) take for product code JFL?
Across 28 cleared submissions the average was 78 days from receipt to decision (median 55).
Which companies have the most JFL clearances?
Sigma Chemical Co. (4); Sigma Diagnostics, Inc. (3); Nova Biomedical Corp. (2); Hichem Diagnostics (2); American Research Products Co. (2).
Have JFL devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2020-01-29.
Next steps
- Run an FDA pathway report with predicate devices for product code JFL
- Run a recall and safety report across every JFL manufacturer
- Watch product code JFL 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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