Product code KWX
- Device name
- Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1187
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K993941 | UBAS | Marukin Diagnostics | 2000-03-02 |
| K980525 | UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD | Marukin Shoyu Co., Ltd. | 1998-04-15 |