Bilirubin(Total) Determination CTMS
FDA 510(k) K820675 · The Dow Chemical Co.
510(k) numberK820675
Submission
- Device name
- Bilirubin(Total) Determination CTMS
- Applicant
- The Dow Chemical Co.
Mchenry, IL, US - Received
- March 11, 1982
- Decision date
- April 1, 1982
- 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 |
|---|---|---|
| K823474 | Enzymatic Glucose DeterminationCGA · Traditional | 12/30/1982SE |
| K822154 | Urea Nitrogen (Enzymatic) DeterminationCDN · Traditional | 08/05/1982SE |
| K821536 | Dowflow Alt-Uv DeterminationCKA · Traditional | 06/14/1982SE |
| K821315 | Dowflow Enzymatic Triglycerides DetermCDT · Traditional | 05/24/1982SE |
| K820714 | Dow Bilirubin(Direct) DeterminationCIG · Traditional | 04/01/1982SE |
| K812777 | Direct Iron Reagent SetJIY · Traditional | 10/19/1981SE |
| K811806 | Quick-Chem ColorimeterJJQ · Traditional | 07/15/1981SE |
| K810861 | Creatine Kinase MB Isoenzyme Immuno UVJHW · Traditional | 04/14/1981SE |
| K810727 | Ast-Uv (Plp-Activated) DeterminationCIT · Traditional | 03/31/1981SE |
| K801501 | UV Uric Acid StandardsJIS · Traditional | 09/26/1980SE |
Questions and answers
When was Bilirubin(Total) Determination CTMS cleared by the FDA?
Bilirubin(Total) Determination CTMS (K820675) received a 510(k) decision of Substantially Equivalent on April 1, 1982, 21 days after the submission was received.
What is the product code of K820675?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.