FDA product code DEL: Lipoprotein X, Antigen, Antiserum, Control
DEL is the FDA product code for lipoprotein x, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5590 and reviewed by the Immunology panel. FDA has cleared 5 510(k) submissions under DEL, from 4 different applicants. The average 510(k) review took 36 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Lipoprotein X, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5590 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DEL clearance
Top DEL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 2 | 1990-04-26 |
| Roche Diagnostics Corp. | 1 | 2001-11-15 |
| Medical Marketing Consultants, Inc. | 1 | 1989-10-06 |
| Catachem, Inc. | 1 | 1989-06-21 |
Most recent DEL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013278 | Roche Diagnostics Corp. | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 | 2001-11-15 | 45 |
| K901675 | Sigma Chemical Co. | APOLIPOPROTEIN A-I (APO A-I) | 1990-04-26 | 16 |
| K900124 | Sigma Chemical Co. | APOLIPOPROTEIN B (APO B) | 1990-03-02 | 52 |
| K895160 | Medical Marketing Consultants, Inc. | ORTHO *APO A-1 ELISA TEST SYSTEM | 1989-10-06 | 44 |
| K893885 | Catachem, Inc. | BACTON TM, BASIC TM, APO A-I REAGENT | 1989-06-21 | 22 |
Recalls for DEL devices
openFDA lists no recalls for product code DEL.
Frequently asked questions
What is FDA product code DEL?
DEL is the FDA product code for lipoprotein x, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5590 and reviewed by the Immunology panel.
What device class is DEL?
Class I, regulation 21 CFR 866.5590. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DEL?
Across 5 cleared submissions the average was 36 days from receipt to decision (median 44).
Which companies have the most DEL clearances?
Sigma Chemical Co. (2); Roche Diagnostics Corp. (1); Medical Marketing Consultants, Inc. (1); Catachem, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DEL
- Run a recall and safety report across every DEL manufacturer
- Watch product code DEL 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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