FDA product code DAY: Complement C5, Antigen, Antiserum, Control
DAY is the FDA product code for complement c5, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under DAY, from 3 different applicants. The average 510(k) review took 216 days (median 92).
Classification
| Field | Value |
|---|---|
| Device name | Complement C5, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5240 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DAY clearance
Top DAY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jay H. Geller | 1 | 1995-08-24 |
| Kent Laboratories, Inc. | 1 | 1995-04-10 |
| Gelman Instrument Co. | 1 | 1978-02-03 |
Most recent DAY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942326 | Jay H. Geller | HUMAN C5 RID KITS | 1995-08-24 | 468 |
| K950102 | Kent Laboratories, Inc. | HUMAN C-5 RADIAL IMMUNODIFFUSION KIT | 1995-04-10 | 89 |
| K772075 | Gelman Instrument Co. | RADIAL IMMUNODIFFUSION KIT-COMPLEMENT | 1978-02-03 | 92 |
Recalls for DAY devices
openFDA lists no recalls for product code DAY.
Frequently asked questions
What is FDA product code DAY?
DAY is the FDA product code for complement c5, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel.
What device class is DAY?
Class II, regulation 21 CFR 866.5240. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAY?
Across 3 cleared submissions the average was 216 days from receipt to decision (median 92).
Which companies have the most DAY clearances?
Jay H. Geller (1); Kent Laboratories, Inc. (1); Gelman Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAY
- Run a recall and safety report across every DAY manufacturer
- Watch product code DAY 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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