Bilirubin (Total)
FDA 510(k) K875069 · Tech-Co, Inc.
510(k) numberK875069
Submission
- Device name
- Bilirubin (Total)
- Applicant
- Tech-Co, Inc.
Oak Park, MI, US - Received
- December 9, 1987
- Decision date
- January 11, 1988
- 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 |
|---|---|---|
| K921968 | In Vitro Diagnostic Reagent Set, Indir. Preg. TestJHJ · Traditional | 06/28/1996SE |
| K923376 | Visual HCG Pregnancy TestJHI · Traditional | 10/01/1992SE |
| K920766 | T4 Eia Bead AssayCDX · Traditional | 04/17/1992SE |
| K920716 | Direct Pregnancy TestJHJ · Traditional | 03/24/1992SE |
| K902574 | Potassium Reagent SetCEJ · Traditional | 07/10/1990SE |
| K901561 | Iron/Total Iron Binding CapacityJIY · Traditional | 05/17/1990SE |
| K883387 | Alanine Amino Transferase (Colorimetric Method)CKD · Traditional | 10/13/1988SE |
| K883683 | HemoglobinGJZ · Traditional | 10/06/1988SE |
| K883386 | ChlorideCHJ · Traditional | 10/06/1988SE |
| K881173 | Aspartate Aminotransferase (Colorimetric Method)CIQ · Traditional | 06/07/1988SE |
Questions and answers
When was Bilirubin (Total) cleared by the FDA?
Bilirubin (Total) (K875069) received a 510(k) decision of Substantially Equivalent on January 11, 1988, 33 days after the submission was received.
What is the product code of K875069?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.