IMMULITE/IMMULITE® 1000 Cortisol
FDA 510(k) K203270 · Siemens Healthcare Diagnostics Products, Ltd.
510(k) numberK203270
Submission
- Device name
- IMMULITE/IMMULITE® 1000 Cortisol
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
Caemarfon, GB - Received
- November 5, 2020
- Decision date
- January 15, 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 |
| K202136 | IDS CortisolCGR · Traditional | Immunodiagnostic Systems , Ltd. | 04/13/2021SE |
| 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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Questions and answers
When was IMMULITE/IMMULITE® 1000 Cortisol cleared by the FDA?
IMMULITE/IMMULITE® 1000 Cortisol (K203270) received a 510(k) decision of Substantially Equivalent on January 15, 2021, 71 days after the submission was received.
What is the product code of K203270?
The FDA product code is CGR – Radioimmunoassay, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.