Direct Bilirubin
FDA 510(k) K930679 · Horizon Diagnostics, Inc.
510(k) numberK930679
Submission
- Device name
- Direct Bilirubin
- Applicant
- Horizon Diagnostics, Inc.
Jackson, MI, US - Received
- February 9, 1993
- Decision date
- June 29, 1993
- 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 |
|---|---|---|
| K971566 | Creatine Kinase-Mb Reagent SetCGS · Traditional | 07/14/1997SE |
| K933722 | Horizon Diagnostics Triglycerides-Gpo ReagentCDT · Traditional | 06/13/1996SE |
| K935712 | Iron/Tibc ReagentJIY · Traditional | 09/20/1995SE |
| K930678 | AmylaseJFJ · Traditional | 04/06/1994SE |
| K934533 | BUN-300/BUN-500 Urea Nitrogen ReagentCDQ · Traditional | 11/26/1993SE |
| K930074 | In-Vitro Diagnostic Reagent SetJGJ · Traditional | 05/11/1993SE |
Questions and answers
When was Direct Bilirubin cleared by the FDA?
Direct Bilirubin (K930679) received a 510(k) decision of Substantially Equivalent on June 29, 1993, 140 days after the submission was received.
What is the product code of K930679?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.