FDA product code CEJ: Tetraphenyl Borate, Colorimetry, Potassium
CEJ is the FDA product code for tetraphenyl borate, colorimetry, potassium. It is a Class II device, regulated under 21 CFR 862.1600 and reviewed by the Clinical Chemistry panel. FDA has cleared 16 510(k) submissions under CEJ, from 14 different applicants. The average 510(k) review took 48 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Tetraphenyl Borate, Colorimetry, Potassium |
| Device class | Class II |
| Regulation | 21 CFR 862.1600 |
| 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 CEJ clearance
Top CEJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Technicon Instruments Corp. | 2 | 1988-11-29 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1988-05-27 |
| Randox Laboratories, Ltd. | 1 | 2005-02-10 |
| Prisma Systems | 1 | 1994-12-09 |
| Boehringer Mannheim Corp. | 1 | 1990-11-06 |
9 more applicants have CEJ clearances. See the full list in Caduvo.
Most recent CEJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K043267 | Randox Laboratories, Ltd. | POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 | 2005-02-10 | 76 |
| K943026 | Prisma Systems | POTASSIUM QVET | 1994-12-09 | 165 |
| K904033 | Boehringer Mannheim Corp. | REFLOTRON POTASSIUM TEST TABS | 1990-11-06 | 67 |
| K902574 | Tech-Co, Inc. | POTASSIUM REAGENT SET | 1990-07-10 | 29 |
| K883585 | Technicon Instruments Corp. | TECHNICON ASSIST POTASSIUM | 1988-11-29 | 98 |
Recalls for CEJ devices
openFDA lists no recalls for product code CEJ.
Frequently asked questions
What is FDA product code CEJ?
CEJ is the FDA product code for tetraphenyl borate, colorimetry, potassium. It is a Class II device, regulated under 21 CFR 862.1600 and reviewed by the Clinical Chemistry panel.
What device class is CEJ?
Class II, regulation 21 CFR 862.1600. Typical premarket route: 510(k).
How long does a 510(k) take for product code CEJ?
Across 16 cleared submissions the average was 48 days from receipt to decision (median 30).
Which companies have the most CEJ clearances?
Technicon Instruments Corp. (2); Bd Becton Dickinson Vacutainer Systems Preanalytic (2); Randox Laboratories, Ltd. (1); Prisma Systems (1); Boehringer Mannheim Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CEJ
- Run a recall and safety report across every CEJ manufacturer
- Watch product code CEJ 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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