FDA product code CEK: Biuret (Colorimetric), Total Protein
CEK is the FDA product code for biuret (colorimetric), total protein. It is a Class II device, regulated under 21 CFR 862.1635 and reviewed by the Clinical Chemistry panel. FDA has cleared 116 510(k) submissions under CEK, from 78 different applicants. The average 510(k) review took 64 days (median 46). FDA has posted 10 recalls for CEK devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Biuret (Colorimetric), Total Protein |
| Device class | Class II |
| Regulation | 21 CFR 862.1635 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CEK clearance
Top CEK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 10 | 1993-12-16 |
| Harleco | 6 | 1981-11-10 |
| Data Medical Associates, Inc. | 4 | 1994-09-06 |
| Beckman Instruments, Inc. | 4 | 1992-11-23 |
| Wako Chemicals USA, Inc. | 3 | 1992-07-14 |
73 more applicants have CEK clearances. See the full list in Caduvo.
Most recent CEK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992846 | Elan Holdings, Inc. | HICHEM TOTAL PROTEIN REAGENT | 1999-10-18 | 55 |
| K973108 | Diagnostic Chemicals , Ltd. | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 | 1998-03-02 | 195 |
| K980042 | Exigent Diagnostics, Inc. | CARESIDE TOTAL PROTEIN | 1998-02-04 | 29 |
| K971524 | Carolina Liquid Chemistries Corp. | TOTAL PROTEIN OR TP | 1997-05-16 | 18 |
| K961864 | Teco Diagnostics | CSF/URINE TOTAL PROTEIN | 1996-10-24 | 163 |
Recalls for CEK devices
10 product recalls in 7 recall events; 4 initiated in the last five years and 6 still open. Most recent: 2025-08-11.
| Year | Recalls |
|---|---|
| 2020 | 2 |
| 2021 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code CEK?
CEK is the FDA product code for biuret (colorimetric), total protein. It is a Class II device, regulated under 21 CFR 862.1635 and reviewed by the Clinical Chemistry panel.
What device class is CEK?
Class II, regulation 21 CFR 862.1635. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CEK?
Across 116 cleared submissions the average was 64 days from receipt to decision (median 46).
Which companies have the most CEK clearances?
Em Diagnostic Systems, Inc. (10); Harleco (6); Data Medical Associates, Inc. (4); Beckman Instruments, Inc. (4); Wako Chemicals USA, Inc. (3).
Have CEK devices been recalled?
Yes: 10 product recalls across 7 recall events; the most recent began 2025-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code CEK
- Run a recall and safety report across every CEK manufacturer
- Watch product code CEK 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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