KWW · Radioimmunoassay, Cholyglycine, Bile Acids
Clinical Chemistry · 21 CFR 862.1177 · Class 2
Overview
| Product Code | KWW |
|---|---|
| Device Name | Radioimmunoassay, Cholyglycine, Bile Acids |
| Regulation | 21 CFR 862.1177 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A cholylglycine test system is a device intended to measure the bile acid cholylglycine 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | Catachem, Inc. | Jan 19, 2007 | SESE |
| K051714 | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | Diazyme Laboratories | Dec 7, 2005 | SESE |
| K970120 | BILE ACIDS REAGENT SET | Teco Diagnostics | Mar 24, 1997 | SESE |
| K872296 | BILE ACIDS REAGENT | Sigma Diagnostics, Inc. | Aug 26, 1987 | SESE |
| K803296 | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT | Immunotech Corp. | Jan 16, 1981 | SESE |
| K781337 | CONJUGATED BILE ACIDS RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 11, 1978 | SESE |
Top Applicants
- Teco Diagnostics — 1 clearance
- Sigma Diagnostics, Inc. — 1 clearance
- Immunotech Corp. — 1 clearance
- Diazyme Laboratories — 1 clearance
- Catachem, Inc. — 1 clearance
