Access Cortisol; DxC 500i Clinical Analyzer
FDA 510(k) K242190 · Beckman Coulter, Inc.
510(k) numberK242190
Submission
- Device name
- Access Cortisol; DxC 500i Clinical Analyzer
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- July 25, 2024
- Decision date
- March 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGR – Radioimmunoassay, Cortisol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1205
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223038 | Access CortisolCGR · Traditional | Beckman Coulter, Inc. | 02/08/2023SE |
| K202136 | IDS CortisolCGR · Traditional | Immunodiagnostic Systems , Ltd. | 04/13/2021SE |
| K203270 | IMMULITE/IMMULITE® 1000 CortisolCGR · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 01/15/2021SE |
| K202826 | IMMULITE® 2000 CortisolCGR · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 01/15/2021SE |
| K062626 | Cortisol ElisaCGR · Traditional | Ibl-Hamburg GmbH | 12/20/2006SE |
| K060480 | Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism…CGR · Traditional | Ortho-Clinical Diagnostics | 07/03/2006SE |
| K052359 | Ibl Cortisol Lia Test KitCGR · Traditional | Lehnus & Associates Consulting | 10/03/2005SE |
| K050202 | Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsCGR · Special | Beckman Coulter, Inc. | 02/09/2005SE |
| K042689 | Nichols Advantage CortisolCGR · Traditional | Nichols Institute Diagnostics | 12/09/2004SE |
| K010790 | Cortisol LiaCGR · Traditional | Kmi Diagnostics, Inc. | 01/29/2002SE |
More from Kmi Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Access Cortisol; DxC 500i Clinical Analyzer cleared by the FDA?
Access Cortisol; DxC 500i Clinical Analyzer (K242190) received a 510(k) decision of Substantially Equivalent on March 5, 2025, 223 days after the submission was received.
What is the product code of K242190?
The FDA product code is CGR – Radioimmunoassay, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.