FDA Product Code
FDA Product Code KWW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1177
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | Catachem, Inc. | 2007-01-19 | Traditional | PDF ↗ |
| K051714 | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | Diazyme Laboratories | 2005-12-07 | Traditional | PDF ↗ |
| K970120 | BILE ACIDS REAGENT SET | Teco Diagnostics | 1997-03-24 | Traditional | PDF ↗ |
| K872296 | BILE ACIDS REAGENT | Sigma Diagnostics, Inc. | 1987-08-26 | Traditional | PDF ↗ |
| K803296 | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT | Immunotech Corp. | 1981-01-16 | Traditional | PDF ↗ |
| K781337 | CONJUGATED BILE ACIDS RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-11 | Traditional | PDF ↗ |
Product code KWW · Class II · Clinical Chemistry. Data: openFDA.