KWX · Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
Clinical Chemistry · 21 CFR 862.1187 · Class 2
Overview
| Product Code | KWX |
|---|---|
| Device Name | Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids |
| Regulation | 21 CFR 862.1187 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A conjugated sulfolithocholic acid (SLCG) test system is a device intended to measure the bile acid SLCG in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K993941 | UBAS | Marukin Diagnostics | Mar 2, 2000 | SESE |
| K980525 | UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD | Marukin Shoyu Co., Ltd. | Apr 15, 1998 | SESE |
Top Applicants
- Marukin Shoyu Co., Ltd. — 1 clearance
- Marukin Diagnostics — 1 clearance
