FDA product code KWX: Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
KWX is the FDA product code for radioimmunoassay, conjugated sulfalithocholic (slcg) acid, bile acids. It is a Class II device, regulated under 21 CFR 862.1187 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under KWX, from 2 different applicants. The average 510(k) review took 84 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids |
| Device class | Class II |
| Regulation | 21 CFR 862.1187 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KWX clearance
Top KWX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marukin Diagnostics | 1 | 2000-03-02 |
| Marukin Shoyu Co., Ltd. | 1 | 1998-04-15 |
Most recent KWX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K993941 | Marukin Diagnostics | UBAS | 2000-03-02 | 104 |
| K980525 | Marukin Shoyu Co., Ltd. | UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD | 1998-04-15 | 63 |
Recalls for KWX devices
openFDA lists no recalls for product code KWX.
Frequently asked questions
What is FDA product code KWX?
KWX is the FDA product code for radioimmunoassay, conjugated sulfalithocholic (slcg) acid, bile acids. It is a Class II device, regulated under 21 CFR 862.1187 and reviewed by the Clinical Chemistry panel.
What device class is KWX?
Class II, regulation 21 CFR 862.1187. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWX?
Across 2 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most KWX clearances?
Marukin Diagnostics (1); Marukin Shoyu Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KWX
- Run a recall and safety report across every KWX manufacturer
- Watch product code KWX 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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