Atac Direct Bilirubin Reagent and Calibrator
FDA 510(k) K030003 · Elan Diagnostics
510(k) numberK030003
Submission
- Device name
- Atac Direct Bilirubin Reagent and Calibrator
- Applicant
- Elan Diagnostics
Brea, CA, US - Received
- January 2, 2003
- Decision date
- September 29, 2003
- 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 |
|---|---|---|
| K030014 | Atac Total Bilirubin ReagentCIG · Traditional | 09/26/2003SE |
| K030621 | Atac CalibratorJIX · Traditional | 03/19/2003SE |
| K023105 | Atac Calcium Reagent and Atac CalibratorCIC · Traditional | 03/13/2003SE |
| K030010 | Atac Pak Magnesium ReagentJGJ · Traditional | 03/10/2003SE |
| K030015 | Atac Pak Phosphorus ReagentCEO · Traditional | 03/07/2003SE |
| K030006 | Atac Pak Albumin ReagentCIX · Traditional | 03/07/2003SE |
| K023407 | Atac Pak Creatinine Reagent and Atac CalibratorCGX · Traditional | 02/14/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | 07/12/2002SE |
| K020575 | Atac Direct LDL Reagent and Atac Direct LDL Calibrator KitsMRR · Traditional | 04/12/2002SE |
| K002285 | Atac Pak Alp Reagent KitCJE · Traditional | 09/26/2000SE |
Questions and answers
When was Atac Direct Bilirubin Reagent and Calibrator cleared by the FDA?
Atac Direct Bilirubin Reagent and Calibrator (K030003) received a 510(k) decision of Substantially Equivalent on September 29, 2003, 270 days after the submission was received.
What is the product code of K030003?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.