ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
FDA 510(k) K170065 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK170065
Submission
- Device name
- ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- January 9, 2017
- Decision date
- March 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFM – Enzymatic Method, Bilirubin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1110
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152343 | Direct BilirubinJFM · Traditional | Randox Laboratories Limited | 02/16/2016SE |
| K152344 | Total BilirubinJFM · Traditional | Randox Laboratories Limited | 01/28/2016SE |
| K063845 | Advia Chemistry Total BILIRUBIN_2JFM · Traditional | Bayer Healthcare, LLC | 12/07/2007SE |
| K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791JFM · Traditional | Wako Chemicals USA, Inc. | 12/30/2005SE |
| K053131 | Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191JFM · Traditional | Wako Chemicals USA, Inc. | 12/30/2005SE |
| K053090 | Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin CalibratorJFM · Traditional | Beckman Coulter, Inc. | 12/16/2005SE |
| K050266 | Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorJFM · Traditional | Stanbio Laboratory | 06/30/2005SE |
| K970985 | Wako Total Bilirubin VJFM · Traditional | Wako Chemicals USA, Inc. | 04/21/1997SE |
| K904660 | Enzymatic Bilirubin (Total), Catalogue No. 202-14JFM · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 11/20/1990SE |
| K843174 | Dri-Stat Enzymatic Bilirubin Test KitJFM · Traditional | Beckman Instruments, Inc. | 09/14/1984SE |
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Questions and answers
When was ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) cleared by the FDA?
ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) (K170065) received a 510(k) decision of Substantially Equivalent on March 9, 2017, 59 days after the submission was received.
What is the product code of K170065?
The FDA product code is JFM – Enzymatic Method, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.