Total Bilirubin Reagent
FDA 510(k) K003892 · Intersect Systems, Inc.
510(k) numberK003892
Submission
- Device name
- Total Bilirubin Reagent
- Applicant
- Intersect Systems, Inc.
Longview, WA, US - Received
- December 18, 2000
- Decision date
- February 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K021636 | Albumin ReagentCJW · Traditional | 07/17/2002SE |
| K011972 | Direct Bilirubin ReagentCIG · Traditional | 08/27/2001SE |
| K011692 | Homogeneous Enzymic Homocysteine ReagentLPS · Traditional | 07/25/2001SE |
| K983937 | Dual Vial Creatinine ReagentCGX · Traditional | 01/06/1999SE |
| K974833 | Ck-Nac ReagentCGS · Traditional | 02/13/1998SE |
| K941807 | Intersect Systems' Non-Mercuric Chloride ReagentCHG · Traditional | 09/14/1994SE |
| K932888 | Intersect Systems Direct Amylase ReagentJFJ · Traditional | 01/31/1994SE |
| K934039 | Intersect Systems HDL Cholesterol Reagent SetLBR · Traditional | 11/16/1993SE |
| K932267 | Enzymatic CO2 Reagent, ModificationKHS · Traditional | 09/24/1993SE |
| K913225 | Urine/Csf Microprotein ReagentCEK · Traditional | 10/11/1991SE |
Questions and answers
When was Total Bilirubin Reagent cleared by the FDA?
Total Bilirubin Reagent (K003892) received a 510(k) decision of Substantially Equivalent on February 20, 2001, 64 days after the submission was received.
What is the product code of K003892?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.