FDA product code OBW: 11-Dehydro Thromboxane B2 Kit, Urinary
OBW is the FDA product code for 11-dehydro thromboxane b2 kit, urinary. It is a Class II device, regulated under 21 CFR 864.5700 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under OBW. The average 510(k) review took 315 days (median 315).
Definition
The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only.
Classification
| Field | Value |
|---|---|
| Device name | 11-Dehydro Thromboxane B2 Kit, Urinary |
| Device class | Class II |
| Regulation | 21 CFR 864.5700 |
| 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 OBW clearance
Top OBW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corgenix, Inc. | 1 | 2007-05-29 |
Most recent OBW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062025 | Corgenix, Inc. | ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 | 2007-05-29 | 315 |
Recalls for OBW devices
openFDA lists no recalls for product code OBW.
Frequently asked questions
What is FDA product code OBW?
OBW is the FDA product code for 11-dehydro thromboxane b2 kit, urinary. It is a Class II device, regulated under 21 CFR 864.5700 and reviewed by the Hematology panel.
What device class is OBW?
Class II, regulation 21 CFR 864.5700. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBW?
Across 1 cleared submissions the average was 315 days from receipt to decision (median 315).
Which companies have the most OBW clearances?
Corgenix, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OBW
- Run a recall and safety report across every OBW manufacturer
- Watch product code OBW 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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