FDA Product Code
FDA Product Code JFM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1110
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | Siemens Healthcare Diagnostics, Inc. | 2017-03-09 | Traditional | PDF ↗ |
| K152343 | Direct Bilirubin | Randox Laboratories Limited | 2016-02-16 | Traditional | PDF ↗ |
| K152344 | Total Bilirubin | Randox Laboratories Limited | 2016-01-28 | Traditional | PDF ↗ |
| K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | Bayer Healthcare, LLC | 2007-12-07 | Traditional | PDF ↗ |
| K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 | Wako Chemicals USA, Inc. | 2005-12-30 | Traditional | PDF ↗ |
| K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 | Wako Chemicals USA, Inc. | 2005-12-30 | Traditional | PDF ↗ |
| K053090 | DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR | Beckman Coulter, Inc. | 2005-12-16 | Traditional | PDF ↗ |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | Stanbio Laboratory | 2005-06-30 | Traditional | PDF ↗ |
| K970985 | WAKO TOTAL BILIRUBIN V | Wako Chemicals USA, Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K904660 | ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 | Diagnostic Chemicals, Ltd. (Usa) | 1990-11-20 | Traditional | PDF ↗ |
| K843174 | DRI-STAT ENZYMATIC BILIRUBIN TEST KIT | Beckman Instruments, Inc. | 1984-09-14 | Traditional | PDF ↗ |
Product code JFM · Class II · Clinical Chemistry. Data: openFDA.