Coulter Total Bilirubin Reagent
FDA 510(k) K901266 · Coulter Corp.
510(k) numberK901266
Submission
- Device name
- Coulter Total Bilirubin Reagent
- Applicant
- Coulter Corp.
Hialeah, FL, US - Received
- March 16, 1990
- Decision date
- April 25, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIG – Diazo Colorimetry, Bilirubin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1110
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/27/2026SE |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/12/2023SE |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/20/2023SE |
| K223324 | Total Bilirubin2CIG · Traditional | Abbott Ireland Diagnostics Division | 12/29/2022SE |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP SlidesCIG · Traditional | Ortho-Clinical Diagnostics, Inc. | 04/26/2019SE |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…CIG · Traditional | Elitechgroup | 07/11/2017SE |
| K150510 | Total BilirubinCIG · Traditional | Abbott Laboratories | 04/02/2015SE |
| K131544 | Cobas C Bilirubin Total GEN.3CIG · Traditional | Roche Diagnostics | 07/17/2013SE |
| K131217 | S Test Reagent Cartridge Total BilirubinCIG · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K123802 | Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentCIG · Traditional | Medica Corp. | 03/01/2013SE |
More from Medica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K993356 | Coulter Hematology Analyzers with Irf & MRV AnalysesGKZ · Traditional | 04/20/2000SE |
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | 05/11/1999SE |
| K990327 | Reticone System for Epics XL Flow Cytometry SystemsGKZ · Traditional | 04/26/1999SE |
| K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…GKZ · Traditional | 04/13/1999SE |
| K990352 | Coulter Ac T Diff 2 AnalyzerGKZ · Traditional | 04/01/1999SE |
| K984216 | Immuno-Trol Control CellsJPK · Traditional | 03/16/1999SE |
| K982167 | Cyto-Stat Trichrome CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent with…GKZ · Traditional | 11/09/1998SE |
| K982166 | Cyto-Stat Trichrome CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with…GKZ · Traditional | 11/05/1998SE |
| K982172 | Cyto-Stat CD3-FITC/CD56-RDI Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone…GKZ · Traditional | 09/24/1998SE |
| K973634 | Coulter Ac.T Diff AnalyzerGKZ · Traditional | 10/29/1997SE |
Questions and answers
When was Coulter Total Bilirubin Reagent cleared by the FDA?
Coulter Total Bilirubin Reagent (K901266) received a 510(k) decision of Substantially Equivalent on April 25, 1990, 40 days after the submission was received.
What is the product code of K901266?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.