Total Bilirubin
FDA 510(k) K152344 · Randox Laboratories Limited
510(k) numberK152344
Submission
- Device name
- Total Bilirubin
- Applicant
- Randox Laboratories Limited
Crumlin, County Antrim, GB - Received
- August 19, 2015
- Decision date
- January 28, 2016
- 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 |
| 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 |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 01/23/2026SE |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 10/05/2023SE |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATDJG · Traditional | 10/05/2023SE |
| K230890 | ISE ElectrodesCEM · Special | 09/08/2023SE |
| K182042 | Randox Calcium (Ca)CJY · Traditional | 10/23/2018SE |
| K162200 | Randox RX Daytona Plus Magnesium (MG)JGJ · Traditional | 04/28/2017SE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | 04/21/2017SE |
| K161691 | Direct LDL Cholesterol (LDL)MRR · Traditional | 03/20/2017SE |
| K152085 | Liquid CO2-2 (LCO2-2)KHS · Traditional | 02/24/2016SE |
| K152343 | Direct BilirubinJFM · Traditional | 02/16/2016SE |
Questions and answers
When was Total Bilirubin cleared by the FDA?
Total Bilirubin (K152344) received a 510(k) decision of Substantially Equivalent on January 28, 2016, 162 days after the submission was received.
What is the product code of K152344?
The FDA product code is JFM – Enzymatic Method, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.