FDA product code DAT: Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
DAT is the FDA product code for fibrinogen and split products, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under DAT, from 2 different applicants. The average 510(k) review took 328 days (median 328).
Classification
| Field | Value |
|---|---|
| Device name | Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 864.7340 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DAT clearance
Top DAT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Organon Teknika Corp. | 1 | 1994-04-21 |
| Medishield, Inc. | 1 | 1978-09-27 |
Most recent DAT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924892 | Organon Teknika Corp. | FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM | 1994-04-21 | 569 |
| K781103 | Medishield, Inc. | SPECTRASCAN | 1978-09-27 | 86 |
Recalls for DAT devices
openFDA lists no recalls for product code DAT.
Frequently asked questions
What is FDA product code DAT?
DAT is the FDA product code for fibrinogen and split products, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel.
What device class is DAT?
Class II, regulation 21 CFR 864.7340. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAT?
Across 2 cleared submissions the average was 328 days from receipt to decision (median 328).
Which companies have the most DAT clearances?
Organon Teknika Corp. (1); Medishield, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAT
- Run a recall and safety report across every DAT manufacturer
- Watch product code DAT 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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