ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
FDA 510(k) clearance K170065 · decided 2017-03-09
Clearance details
- K-number
- K170065
- Device name
- ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-09
- Decision date
- 2017-03-09
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- JFM
- Device class
- 2
- Regulation number
- 862.1110
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Direct Bilirubin (K152343) | Randox Laboratories Limited | 2016-02-16 |
| Total Bilirubin (K152344) | Randox Laboratories Limited | 2016-01-28 |
| ADVIA CHEMISTRY TOTAL BILIRUBIN_2 (K063845) | Bayer Healthcare, LLC | 2007-12-07 |
| WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 (K053132) | Wako Chemicals USA, Inc. | 2005-12-30 |
| WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 (K053131) | Wako Chemicals USA, Inc. | 2005-12-30 |
| DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR (K053090) | Beckman Coulter, Inc. | 2005-12-16 |
| DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (K050266) | Stanbio Laboratory | 2005-06-30 |
| WAKO TOTAL BILIRUBIN V (K970985) | Wako Chemicals USA, Inc. | 1997-04-21 |
| ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 (K904660) | Diagnostic Chemicals, Ltd. (Usa) | 1990-11-20 |
| DRI-STAT ENZYMATIC BILIRUBIN TEST KIT (K843174) | Beckman Instruments, Inc. | 1984-09-14 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination o recall (Z-2471-2023) | Siemens Healthcare Diagnostics, Inc. | 2023-08-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 PSA (P930027/S039) | Siemens Healthcare Diagnostics, Inc. | 2026-07-27 |
| IMMULITE 2000 AFP (P010007/S026) | Siemens Healthcare Diagnostics, Inc. | 2026-07-27 |
| Atellica IM free PSA II (fPSAII) (P250026) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) (P930036/S026) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| IMMULITE 2000 AFP (P010007/S025) | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| IMMULITE 2000 PSA (P930027/S038) | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |