Zeta-Cort
FDA 510(k) K821931 · Amf Biological and Diagnostics Co.
510(k) numberK821931
Submission
- Device name
- Zeta-Cort
- Applicant
- Amf Biological and Diagnostics Co.
Mchenry, IL, US - Received
- June 29, 1982
- Decision date
- July 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Nichols Institute Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K852418 | QCM-SP1(NORMAL Concenttration) & SP2(ABNORMAL)JJY · Traditional | 07/15/1985SE |
| K821554 | Zetaphase T4 Radioimmunoassay Diag. KitCDX · Traditional | 06/25/1982SE |
| K821553 | Zetaphase T3 Uptake Diagnostic KitKHQ · Traditional | 06/25/1982SE |
| K812329 | Zeta-Sera DKIS · Traditional | 09/01/1981SE |
Questions and answers
When was Zeta-Cort cleared by the FDA?
Zeta-Cort (K821931) received a 510(k) decision of Substantially Equivalent on July 22, 1982, 23 days after the submission was received.
What is the product code of K821931?
The FDA product code is CGR – Radioimmunoassay, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.