510(k) K053090
- Device
- DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K053090
- Product code
- JFM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-12-16
- Date received
- 2005-11-02
- Regulation
- 862.1110
- Classification name
- Enzymatic Method, Bilirubin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERI HIRUMI
- Address
- 200 S. Kraemer Blvd. W-110 Brea CA US 92822 92822
FDA Registration Numbers#
- 1616487
- 2517506
- 2050010
- 2050012
- 3004493545
- 2432235
Source Documents#
Other 510(k) Records For Product Code JFM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | Siemens Healthcare Diagnostics, Inc. | 2017-03-09 |
| K152343 | Direct Bilirubin | Randox Laboratories Limited | 2016-02-16 |
| K152344 | Total Bilirubin | Randox Laboratories Limited | 2016-01-28 |
| K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | Bayer Healthcare, LLC | 2007-12-07 |
| K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 | Wako Chemicals USA, Inc. | 2005-12-30 |
| K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 | Wako Chemicals USA, Inc. | 2005-12-30 |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | Stanbio Laboratory | 2005-06-30 |
| K970985 | WAKO TOTAL BILIRUBIN V | Wako Chemicals USA, Inc. | 1997-04-21 |
| K904660 | ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 | Diagnostic Chemicals, Ltd. (Usa) | 1990-11-20 |
| K843174 | DRI-STAT ENZYMATIC BILIRUBIN TEST KIT | Beckman Instruments, Inc. | 1984-09-14 |
Legacy Summary#
summary
FDA Review#
Decision Summary