FDA product code DEX: Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
DEX is the FDA product code for alpha-1-b-glycoprotein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5420 and reviewed by the Immunology panel. FDA has cleared 5 510(k) submissions under DEX, from 5 different applicants. The average 510(k) review took 34 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5420 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DEX clearance
Top DEX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kent Laboratories, Inc. | 1 | 1982-12-30 |
| J.T. Baker Chemical Co. | 1 | 1980-09-26 |
| Beckman Instruments, Inc. | 1 | 1979-08-16 |
| Icl Scientific | 1 | 1978-08-14 |
| Oxford Laboratories, Inc. | 1 | 1976-07-20 |
Most recent DEX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823765 | Kent Laboratories, Inc. | ANTI SERA TO HUMAN OROSCOMUCOID | 1982-12-30 | 16 |
| K801909 | J.T. Baker Chemical Co. | LSA 290 ASSAY REAGENTS/NEPHELOMETRIC | 1980-09-26 | 46 |
| K791341 | Beckman Instruments, Inc. | HUMAN ALPHA, ACID GLYCOPROTEIN | 1979-08-16 | 31 |
| K781023 | Icl Scientific | ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU | 1978-08-14 | 56 |
| K760143 | Oxford Laboratories, Inc. | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | 1976-07-20 | 21 |
Recalls for DEX devices
openFDA lists no recalls for product code DEX.
Frequently asked questions
What is FDA product code DEX?
DEX is the FDA product code for alpha-1-b-glycoprotein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5420 and reviewed by the Immunology panel.
What device class is DEX?
Class I, regulation 21 CFR 866.5420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DEX?
Across 5 cleared submissions the average was 34 days from receipt to decision (median 31).
Which companies have the most DEX clearances?
Kent Laboratories, Inc. (1); J.T. Baker Chemical Co. (1); Beckman Instruments, Inc. (1); Icl Scientific (1); Oxford Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DEX
- Run a recall and safety report across every DEX manufacturer
- Watch product code DEX 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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