FDA product code DAP: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
DAP is the FDA product code for fibrinogen and fibrin split products, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 864.7320 and reviewed by the Hematology panel. FDA has cleared 58 510(k) submissions under DAP, 1 in the last five years, from 22 different applicants. The average 510(k) review took 139 days (median 124); 242 days on average over the last three years. FDA has posted 13 recalls for DAP devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 864.7320 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DAP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 61 |
| 2026 | 1 | 242 |
Compare with all 510(k) review times · Search every DAP clearance
Top DAP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 9 | 2017-11-22 |
| Dade Behring, Inc. | 6 | 2007-03-23 |
| Organon Teknika Corp. | 5 | 2000-06-07 |
| bioMerieux, Inc. | 4 | 2012-07-31 |
| Siemens Healthcare Diagnostics | 4 | 2011-05-16 |
17 more applicants have DAP clearances. See the full list in Caduvo.
Most recent DAP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253985 | Siemens Healthcare Diagnostic Products GmbH | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | 2026-08-11 | 242 |
| K172903 | Instrumentation Laboratory CO | HemosIL D-Dimer HS 500 | 2017-11-22 | 61 |
| K162227 | Diagnostica Stago | STA® - Liatest® D-Di | 2016-12-10 | 124 |
| K160885 | Instrumentation Laboratory CO | HemosIL D-Dimer HS | 2016-10-27 | 210 |
| K151534 | Instrumentation Laboratory CO | HemosIL D-Dimer HS | 2015-07-06 | 28 |
Recalls for DAP devices
13 product recalls in 12 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2026-02-05.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code DAP?
DAP is the FDA product code for fibrinogen and fibrin split products, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 864.7320 and reviewed by the Hematology panel.
What device class is DAP?
Class II, regulation 21 CFR 864.7320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAP?
Across 58 cleared submissions the average was 139 days from receipt to decision (median 124).
Which companies have the most DAP clearances?
Instrumentation Laboratory CO (9); Dade Behring, Inc. (6); Organon Teknika Corp. (5); bioMerieux, Inc. (4); Siemens Healthcare Diagnostics (4).
Have DAP devices been recalled?
Yes: 13 product recalls across 12 recall events; the most recent began 2026-02-05.
Next steps
- Run an FDA pathway report with predicate devices for product code DAP
- Run a recall and safety report across every DAP manufacturer
- Watch product code DAP 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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