FDA product code CEI: Uranyl Acetate/Zinc Acetate, Sodium
CEI is the FDA product code for uranyl acetate/zinc acetate, sodium. It is a Class II device, regulated under 21 CFR 862.1665 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under CEI, from 4 different applicants. The average 510(k) review took 53 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Uranyl Acetate/Zinc Acetate, Sodium |
| Device class | Class II |
| Regulation | 21 CFR 862.1665 |
| 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 CEI clearance
Top CEI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Randox Laboratories, Ltd. | 1 | 2005-02-15 |
| Sterling Diagnostics, Inc. | 1 | 1991-10-31 |
| Tech Intl. Co. | 1 | 1990-07-10 |
| Mallinckrodt Critical Care | 1 | 1983-09-20 |
Most recent CEI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K043268 | Randox Laboratories, Ltd. | SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 | 2005-02-15 | 81 |
| K914039 | Sterling Diagnostics, Inc. | SODIUM REAGENT SET | 1991-10-31 | 51 |
| K902572 | Tech Intl. Co. | SODIUM REAGENT SET | 1990-07-10 | 29 |
| K832552 | Mallinckrodt Critical Care | SODIUM TEST KIT | 1983-09-20 | 50 |
Recalls for CEI devices
openFDA lists no recalls for product code CEI.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J0702 — Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg
Frequently asked questions
What is FDA product code CEI?
CEI is the FDA product code for uranyl acetate/zinc acetate, sodium. It is a Class II device, regulated under 21 CFR 862.1665 and reviewed by the Clinical Chemistry panel.
What device class is CEI?
Class II, regulation 21 CFR 862.1665. Typical premarket route: 510(k).
How long does a 510(k) take for product code CEI?
Across 4 cleared submissions the average was 53 days from receipt to decision (median 50).
Which companies have the most CEI clearances?
Randox Laboratories, Ltd. (1); Sterling Diagnostics, Inc. (1); Tech Intl. Co. (1); Mallinckrodt Critical Care (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CEI
- Run a recall and safety report across every CEI manufacturer
- Watch product code CEI 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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