KWW
6 FDA 510(k) clearances · Product code
71 daysmedian time to decision
163 days90th percentile
6clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Cholyglycine, Bile Acids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1177
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (K062503) | Catachem, Inc. | 2007-01-19 |
| TOTAL BILE ACIDS ASSAY, MODEL DZ042A (K051714) | Diazyme Laboratories | 2005-12-07 |
| BILE ACIDS REAGENT SET (K970120) | Teco Diagnostics | 1997-03-24 |
| BILE ACIDS REAGENT (K872296) | Sigma Diagnostics, Inc. | 1987-08-26 |
| ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT (K803296) | Immunotech Corp. | 1981-01-16 |
| CONJUGATED BILE ACIDS RIA KIT (K781337) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-11 |
Track KWW automatically
Every clearance here is in the API, with alerts when new ones post.