In-Vitro Test Determination Total Bilirubin
FDA 510(k) K854180 · Clinical Data, Inc.
510(k) numberK854180
Submission
- Device name
- In-Vitro Test Determination Total Bilirubin
- Applicant
- Clinical Data, Inc.
Boston, MA, US - Received
- October 15, 1985
- Decision date
- November 25, 1985
- 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 |
|---|---|---|
| K071706 | Envoy 500 HDL; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118)LBS · Traditional | 12/20/2007SE |
| K052591 | Nanopia Wide Range C-Reactive Protein (CRP) Reagent KitDCK · Traditional | 02/09/2006SE |
| K033983 | Vitalab Iron ReagentJIY · Traditional | 05/21/2004SE |
| K040631 | Vitalab Direct Bilirubin ReagentCIG · Traditional | 03/18/2004SE |
| K040534 | Vitalab Amylase ReagentJFJ · Traditional | 03/11/2004SE |
| K034000 | Vitalab Triglycerides Reagent and Vitalab CalibratorCDT · Traditional | 03/10/2004SE |
| K040508 | Vitalab Magnesium ReagentJGJ · Traditional | 03/08/2004SE |
| K040467 | Vitalab Uric Acid ReagentKNK · Traditional | 03/08/2004SE |
| K031042 | Atac Hemoglobin A1C Reagent KitLCP · Traditional | 11/03/2003SE |
| K031044 | Atac Pak Uric Acid Reagent and Atac CalibratorKNK · Traditional | 07/15/2003SE |
Questions and answers
When was In-Vitro Test Determination Total Bilirubin cleared by the FDA?
In-Vitro Test Determination Total Bilirubin (K854180) received a 510(k) decision of Substantially Equivalent on November 25, 1985, 41 days after the submission was received.
What is the product code of K854180?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.