FDA product code CEE: Radioimmunoassay, Thyroxine-Binding Globulin
CEE is the FDA product code for radioimmunoassay, thyroxine-binding globulin. It is a Class II device, regulated under 21 CFR 862.1685 and reviewed by the Clinical Chemistry panel. FDA has cleared 25 510(k) submissions under CEE, from 20 different applicants. The average 510(k) review took 53 days (median 43). FDA has posted 1 recall for CEE devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Thyroxine-Binding Globulin |
| Device class | Class II |
| Regulation | 21 CFR 862.1685 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CEE clearance
Top CEE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boehringer Mannheim Corp. | 3 | 1990-03-01 |
| Nuclear Diagnostics, Inc. | 3 | 1986-06-13 |
| Immunotech Corp. | 2 | 1991-01-30 |
| Johnson & Johnson Clinical Diagnostics, Inc. | 1 | 1995-07-26 |
| Bio-Rad Laboratories, Inc. | 1 | 1993-06-07 |
15 more applicants have CEE clearances. See the full list in Caduvo.
Most recent CEE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952284 | Johnson & Johnson Clinical Diagnostics, Inc. | AMERLITE TBG ASSAY | 1995-07-26 | 71 |
| K930010 | Bio-Rad Laboratories, Inc. | ACCESS THYROID UPTAKE ASSAY | 1993-06-07 | 154 |
| K910677 | Cirrus Diagnostics, Inc. | IMMULITE(TM) T-UPTAKE | 1991-04-29 | 73 |
| K905777 | Immunotech Corp. | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | 1991-01-30 | 34 |
| K900240 | Pharmacia, Inc. | DELFIA TBG KIT | 1990-03-30 | 72 |
Recalls for CEE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-04-09.
Frequently asked questions
What is FDA product code CEE?
CEE is the FDA product code for radioimmunoassay, thyroxine-binding globulin. It is a Class II device, regulated under 21 CFR 862.1685 and reviewed by the Clinical Chemistry panel.
What device class is CEE?
Class II, regulation 21 CFR 862.1685. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CEE?
Across 25 cleared submissions the average was 53 days from receipt to decision (median 43).
Which companies have the most CEE clearances?
Boehringer Mannheim Corp. (3); Nuclear Diagnostics, Inc. (3); Immunotech Corp. (2); Johnson & Johnson Clinical Diagnostics, Inc. (1); Bio-Rad Laboratories, Inc. (1).
Have CEE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code CEE
- Run a recall and safety report across every CEE manufacturer
- Watch product code CEE 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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