Bilirubin Standard
by Verichem Laboratories, Inc.
510(k) K882059
Bilirubin Standard is a medical device (FDA Class II; FDA product code JIT, Calibrator, Secondary) made by Verichem Laboratories, Inc., cleared under FDA 510(k) K882059 on 25 Oct 1988, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882059 | Date25 Oct 1988 | StatusActive |
Official records
- FDA 510(k) database K882059
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JIT
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K882059
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Bilirubin Mid-Range Standard 9575 | 9575 | 00852553007322 | — | On the market |
| Bilirubin Standard Kit 9450 | 9450 | 00852553007063 | Total Volume 50 mL | On the market |
| Bilirubin Standard, Level F 9436 | 9436 | 00852553007070 | Total Volume 10 mL | On the market |
| BR2 Bilirubin Calibrator 9459 | 9459 | 00852553007117 | Total Volume 10 mL | On the market |
| Tru-Zero Bilirubin Standard 9456 | 9456 | 00852553007308 | — | On the market |
Similar devices
Other devices filed under FDA product code JIT (Calibrator, Secondary).
- ARCHITECT 4P52-01 04P5201 by Abbott
- DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH by DIAMOND DIAGNOSTICS Inc
- Dimension® MYO Calibrator 10445024 RC422 by Siemens Healthcare Diagnostics Inc.
- CO2 CALIBRATOR/DILUENT by Bayer Healthcare, Diagnostics Division
- ST AIA-PACK PROG II Calibrator Set by TOSOH BIOSCIENCE, INC.
- CALIBRATING MATERIAL, CALIBRATING STANDARDS by DIAMOND DIAGNOSTICS Inc
- ACE Calibrator 06U8601 by Sentinel Ch. Srl
- ABSORBANCE TEST SOLUTION by Diagnostic Systems
- ARCHITECT 1L77-01 01L7701 by Abbott Ireland Diagnostics
- ELECTROPHORESIS CONTROL by Seradyn, Inc.