Product code JFM
- Device name
- Enzymatic Method, Bilirubin
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1110
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | Siemens Healthcare Diagnostics, Inc. | 2017-03-09 |
| K152343 | Direct Bilirubin | Randox Laboratories Limited | 2016-02-16 |
| K152344 | Total Bilirubin | Randox Laboratories Limited | 2016-01-28 |
| K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | Bayer Healthcare, LLC | 2007-12-07 |
| K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 | Wako Chemicals USA, Inc. | 2005-12-30 |
| K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 | Wako Chemicals USA, Inc. | 2005-12-30 |
| K053090 | DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR | Beckman Coulter, Inc. | 2005-12-16 |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | Stanbio Laboratory | 2005-06-30 |
| K970985 | WAKO TOTAL BILIRUBIN V | Wako Chemicals USA, Inc. | 1997-04-21 |
| K904660 | ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 | Diagnostic Chemicals, Ltd. (Usa) | 1990-11-20 |
| K843174 | DRI-STAT ENZYMATIC BILIRUBIN TEST KIT | Beckman Instruments, Inc. | 1984-09-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05055273214772 | TOTAL BILIRUBIN 2 (T BIL 2) | RANDOX LABORATORIES LIMITED | 2022-10-04 |
| 05055273214796 | DIRECT BILIRUBIN 2 (D BIL 2) | RANDOX LABORATORIES LIMITED | 2022-10-04 |
| 00630414595801 | Atellica CH DBil_2 | Siemens Healthcare Diagnostics Inc. | 2017-12-26 |
| 00630414595818 | Atellica CH TBil_2 | Siemens Healthcare Diagnostics Inc. | 2017-12-21 |
| 00630414513065 | ADVIA® Chemistry Direct Bilirubin_2 DBIL_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414513072 | ADVIA® Chemistry TBIL_2 Total Bilirubin_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414513089 | ADVIA® Chemistry DBIL_2 Direct Bilirubin 2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414513058 | ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00657498000564 | Direct Bilirubin LiquiColor® | STANBIO LABORATORY, L.P. | 2016-09-23 |
| 00657498000588 | Total Bilirubin LiquiColor® | STANBIO LABORATORY, L.P. | 2016-09-23 |
| 00657498001486 | Sirrus® Total Bilirubin LiquiColor® | STANBIO LABORATORY, L.P. | 2016-09-23 |
| 00657498001493 | Sirrus® Direct Bilirubin LiquiColor® | STANBIO LABORATORY, L.P. | 2016-09-23 |
| 05055273208306 | T BIL | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05055273208313 | D BIL | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05055273208320 | D BIL | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05055273208337 | T BIL | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 15099590222642 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |