FDA product code CDX: Radioimmunoassay, Total Thyroxine
CDX is the FDA product code for radioimmunoassay, total thyroxine. It is a Class II device, regulated under 21 CFR 862.1700 and reviewed by the Clinical Chemistry panel. FDA has cleared 121 510(k) submissions under CDX, from 75 different applicants. The average 510(k) review took 50 days (median 38). FDA has posted 1 recall for CDX devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Total Thyroxine |
| Device class | Class II |
| Regulation | 21 CFR 862.1700 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CDX clearance
Top CDX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 6 | 1994-06-21 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 6 | 1991-01-17 |
| Diagnostic Products Corp. | 4 | 1991-08-12 |
| Micromedic Systems | 4 | 1987-05-26 |
| Bio-Rad | 4 | 1981-07-10 |
70 more applicants have CDX clearances. See the full list in Caduvo.
Most recent CDX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961490 | Boehringer Mannheim Corp. | ELECSYS T4 ASSAY | 1996-06-13 | 56 |
| K954312 | Diagnostic Systems Laboratories, Inc. | ACTIVE THYROXINE RIA | 1995-10-07 | 22 |
| K943416 | Wallac OY | DELFIA NEONATAL THYROXINE KIT | 1995-03-10 | 238 |
| K934384 | Abbott Laboratories | AXSYM(TM) TOTAL T4 | 1994-06-21 | 293 |
| K932980 | Sigma Diagnostics, Inc. | TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 | 1993-10-18 | 123 |
Recalls for CDX devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-06-04.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code CDX?
CDX is the FDA product code for radioimmunoassay, total thyroxine. It is a Class II device, regulated under 21 CFR 862.1700 and reviewed by the Clinical Chemistry panel.
What device class is CDX?
Class II, regulation 21 CFR 862.1700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CDX?
Across 121 cleared submissions the average was 50 days from receipt to decision (median 38).
Which companies have the most CDX clearances?
Abbott Laboratories (6); Bd Becton Dickinson Vacutainer Systems Preanalytic (6); Diagnostic Products Corp. (4); Micromedic Systems (4); Bio-Rad (4).
Have CDX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-06-04.
Next steps
- Run an FDA pathway report with predicate devices for product code CDX
- Run a recall and safety report across every CDX manufacturer
- Watch product code CDX 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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