Advia Chemistry Total BILIRUBIN_2
FDA 510(k) K063845 · Bayer Healthcare, LLC
510(k) numberK063845
Submission
- Device name
- Advia Chemistry Total BILIRUBIN_2
- Applicant
- Bayer Healthcare, LLC
Tarrytown, NY, US - Received
- December 27, 2006
- Decision date
- December 7, 2007
- 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 |
|---|---|---|---|
| K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)JFM · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/09/2017SE |
| K152343 | Direct BilirubinJFM · Traditional | Randox Laboratories Limited | 02/16/2016SE |
| K152344 | Total BilirubinJFM · Traditional | Randox Laboratories Limited | 01/28/2016SE |
| 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 |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)NUH · Traditional | 03/07/2018SE |
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)NUH · Traditional | 12/22/2015SE |
| K150942 | Contour Next USB Blood Glucose Monitoring SystemNBW · Special | 11/25/2015SE |
| K151742 | Contour Next Control SolutionJJX · Traditional | 09/23/2015SE |
| K130265 | Contour Next Ez Blood Glucose MeterNBW · Traditional | 06/23/2014SE |
| K122370 | Contour Next Link Wireless Blood Glucose MonitorNBW · Traditional | 09/26/2013SE |
| K121190 | Contour Next Blood Glucose MeterLFR · Special | 07/26/2012SE |
| K121087 | Contour Next Usb Blood Glucose Monitoring SystemNBW · Special | 06/28/2012SE |
| K110894 | Contour Next Link Wireless Blood Glucose MeterLFR · Traditional | 03/28/2012SE |
| K110587 | Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…LFR · Traditional | 03/28/2012SE |
Questions and answers
When was Advia Chemistry Total BILIRUBIN_2 cleared by the FDA?
Advia Chemistry Total BILIRUBIN_2 (K063845) received a 510(k) decision of Substantially Equivalent on December 7, 2007, 345 days after the submission was received.
What is the product code of K063845?
The FDA product code is JFM – Enzymatic Method, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.