Gilchem Total Bilirubin Reagent
FDA 510(k) K831843 · Gilford Diagnostics
510(k) numberK831843
Submission
- Device name
- Gilchem Total Bilirubin Reagent
- Applicant
- Gilford Diagnostics
Mchenry, IL, US - Received
- June 8, 1983
- Decision date
- July 18, 1983
- 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 |
|---|---|---|
| K832094 | Bilirubin Calibrators & ControlJIT · Traditional | 08/11/1983SE |
| K831844 | Direct Bilirubin ReagentCIG · Traditional | 07/18/1983SE |
| K823709 | Triglyceride Reagent (UV)CDT · Traditional | 01/07/1983SE |
| K822739 | AhbdJMK · Traditional | 10/18/1982SE |
| K822334 | Bilirubin CalibratorsJIT · Traditional | 09/02/1982SE |
| K822289 | CO2/CI StandardsJIX · Traditional | 08/24/1982SE |
| K822149 | Gilchem Y-Gt ReagentJPZ · Traditional | 08/12/1982SE |
| K821719 | Ammonia ReagentJIF · Traditional | 06/24/1982SE |
| K820976 | Gil Chem Magnesium ReagentJGJ · Traditional | 04/26/1982SE |
| K820975 | Gilchem Acid Phosphatase ReagentCKB · Traditional | 04/26/1982SE |
Questions and answers
When was Gilchem Total Bilirubin Reagent cleared by the FDA?
Gilchem Total Bilirubin Reagent (K831843) received a 510(k) decision of Substantially Equivalent on July 18, 1983, 40 days after the submission was received.
What is the product code of K831843?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.