Total Bilirubin Reagent
FDA 510(k) K840486 · Somas Medical Industries, Inc.
510(k) numberK840486
Submission
- Device name
- Total Bilirubin Reagent
- Applicant
- Somas Medical Industries, Inc.
Mchenry, IL, US - Received
- February 6, 1984
- Decision date
- April 25, 1984
- 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 |
|---|---|---|
| K862179 | Somas Liquid Urine ControlJJY · Traditional | 07/01/1986SE |
| K842134 | Somas Coomasie Blue Total Protein AssayJGQ · Traditional | 07/06/1984SE |
| K840974 | Somas Human Spinal Fluid ControlDFI · Traditional | 04/05/1984SE |
| K840485 | Total Iron Uibc/Tibc AssayCFM · Traditional | 03/12/1984SE |
| K833787 | Somas Chloride Assay Kit · Traditional | 01/11/1984SE |
Questions and answers
When was Total Bilirubin Reagent cleared by the FDA?
Total Bilirubin Reagent (K840486) received a 510(k) decision of Substantially Equivalent on April 25, 1984, 79 days after the submission was received.
What is the product code of K840486?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.