Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791
FDA 510(k) K053132 · Wako Chemicals USA, Inc.
510(k) numberK053132
Submission
- Device name
- Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791
- Applicant
- Wako Chemicals USA, Inc.
Richmond, VA, US - Received
- November 8, 2005
- Decision date
- December 30, 2005
- 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 |
| K063845 | Advia Chemistry Total BILIRUBIN_2JFM · Traditional | Bayer Healthcare, LLC | 12/07/2007SE |
| 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 |
|---|---|---|
| K100464 | Utaswako I30 (Includes Accessories), Utaswako AFP-L3, Calibrator Set, Control L, Control…NSF · Traditional | 02/23/2011SE |
| K080125 | Apolowako T-Cho, Hdl-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…LBS · Traditional | 07/18/2008SE |
| K080123 | Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201CFR · Traditional | 07/17/2008SE |
| K061775 | Wako L-Type Creatinine-M Test, and Wako Creatinine CalibratorJFY · Traditional | 02/23/2007SE |
| K062368 | Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP…OAU · Traditional | 01/31/2007SE |
| K053131 | Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191JFM · Traditional | 12/30/2005SE |
| K042551 | Multi-Chem Calibrator aJIX · Traditional | 11/16/2004SE |
| K042550 | Multi-Lipid CalibratorJIX · Traditional | 11/08/2004SE |
| K042549 | Multi Chem Cal BJIX · Traditional | 11/08/2004SE |
| K040918 | Wako Lipid Control, Level 1 and Level 2JJX · Traditional | 05/17/2004SE |
Questions and answers
When was Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 cleared by the FDA?
Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 (K053132) received a 510(k) decision of Substantially Equivalent on December 30, 2005, 52 days after the submission was received.
What is the product code of K053132?
The FDA product code is JFM – Enzymatic Method, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.