KWW — Radioimmunoassay, Cholyglycine, Bile Acids Class II
FDA Device Classification
Classification Details
- Product Code
- KWW
- Device Class
- Class II
- Regulation Number
- 862.1177
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K062503 | catachem | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | January 19, 2007 |
| K051714 | diazyme laboratories | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | December 7, 2005 |
| K970120 | teco diagnostics | BILE ACIDS REAGENT SET | March 24, 1997 |
| K872296 | sigma diagnostics | BILE ACIDS REAGENT | August 26, 1987 |
| K803296 | immunotech | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT | January 16, 1981 |
| K781337 | bd becton dickinson vacutainer systems preanalytic | CONJUGATED BILE ACIDS RIA KIT | August 11, 1978 |