IDS Cortisol
FDA 510(k) K202136 · Immunodiagnostic Systems , Ltd.
510(k) numberK202136
Submission
- Device name
- IDS Cortisol
- Applicant
- Immunodiagnostic Systems , Ltd.
Boldon, GB - Received
- July 31, 2020
- Decision date
- April 13, 2021
- 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 |
|---|---|---|---|
| K242190 | Access Cortisol; DxC 500i Clinical AnalyzerCGR · Traditional | Beckman Coulter, Inc. | 03/05/2025SE |
| K223038 | Access CortisolCGR · Traditional | Beckman Coulter, Inc. | 02/08/2023SE |
| 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 |
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| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG · Traditional | 11/15/2016SE |
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Questions and answers
When was IDS Cortisol cleared by the FDA?
IDS Cortisol (K202136) received a 510(k) decision of Substantially Equivalent on April 13, 2021, 256 days after the submission was received.
What is the product code of K202136?
The FDA product code is CGR – Radioimmunoassay, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.