Enzymatic Bilirubin (Total), Catalogue No. 202-14
FDA 510(k) K904660 · Diagnostic Chemicals, Ltd. (Usa)
510(k) numberK904660
Submission
- Device name
- Enzymatic Bilirubin (Total), Catalogue No. 202-14
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
Charlottestown,Pei,Canada, CA - Received
- October 15, 1990
- Decision date
- November 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| K843174 | Dri-Stat Enzymatic Bilirubin Test KitJFM · Traditional | Beckman Instruments, Inc. | 09/14/1984SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K022538 | Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special | 08/23/2002SE |
| K974874 | Bilirubin-Sl (Total) AssayCIG · Traditional | 02/12/1998SE |
| K932556 | Ammonia Assay Cat. No. 200-02JIF · Traditional | 08/02/1994SE |
| K932766 | Hdl-Cholestral(Dextran Sulfate/Magnesium)LBR · Traditional | 12/10/1993SE |
| K932555 | Dc-Lineate Cat. No. SE-091JIS · Traditional | 08/19/1993SE |
| K925877 | Dc-Uibc-CalJIS · Traditional | 03/18/1993SE |
| K912825 | Magnesium Assay Kit, Cat.# 100-12JGJ · Traditional | 07/26/1991SE |
| K895964 | DCL Syphilis-M Catalog No. 600-80LIP · Traditional | 01/08/1991SE |
| K895965 | DCL - Syphilis-G Assay Catalog No. 600-70LIP · Traditional | 12/26/1990SE |
| K901510 | Enzymatic Theophylline Reagent, #500-82KLS · Traditional | 06/12/1990SE |
Questions and answers
When was Enzymatic Bilirubin (Total), Catalogue No. 202-14 cleared by the FDA?
Enzymatic Bilirubin (Total), Catalogue No. 202-14 (K904660) received a 510(k) decision of Substantially Equivalent on November 20, 1990, 36 days after the submission was received.
What is the product code of K904660?
The FDA product code is JFM – Enzymatic Method, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.