Careside Direct Bilirubin
FDA 510(k) K993771 · Careside, Inc.
510(k) numberK993771
Submission
- Device name
- Careside Direct Bilirubin
- Applicant
- Careside, Inc.
Culver City, CA, US - Received
- November 8, 1999
- Decision date
- December 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K020484 | Careside LDHCFH · Traditional | 07/03/2002SE |
| K020486 | Careside GGTJPZ · Traditional | 07/01/2002SE |
| K020487 | Careside AltCKA · Traditional | 06/04/2002SE |
| K020488 | Careside TrglycerideCDT · Traditional | 04/15/2002SE |
| K002792 | Careside CholinesteraseDIH · Traditional | 11/08/2000SE |
| K001462 | Careside HemoglobinKHG · Traditional | 08/21/2000SE |
| K993634 | Careside AnalyzerJJF · Traditional | 12/02/1999SE |
| K992475 | Careside CO2, TotalKHS · Traditional | 09/15/1999SE |
| K991717 | Careside MGJGJ · Traditional | 08/10/1999SE |
| K991371 | Careside AmmoniaJID · Traditional | 08/03/1999SE |
Questions and answers
When was Careside Direct Bilirubin cleared by the FDA?
Careside Direct Bilirubin (K993771) received a 510(k) decision of Substantially Equivalent on December 27, 1999, 49 days after the submission was received.
What is the product code of K993771?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.