Radioimmunoassay of No Spin(Tm) Cortisol
FDA 510(k) K862871 · Cambridge Medical Technology
510(k) numberK862871
Submission
- Device name
- Radioimmunoassay of No Spin(Tm) Cortisol
- Applicant
- Cambridge Medical Technology
Billerica, MA, US - Received
- July 29, 1986
- Decision date
- August 19, 1986
- 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 |
|---|---|---|
| K890837 | Ria-Gnost InsulinCFP · Traditional | 04/26/1989SE |
| K890836 | Ria-Gnost ProgesteroneJLS · Traditional | 03/16/1989SE |
| K890697 | Ria-Gnost FerritinJMG · Traditional | 03/16/1989SE |
| K873737 | No Spin(Tm) T3 Coated Tube RadioimmunoassayCDP · Traditional | 11/24/1987SE |
| K870573 | T4 No Spin(Tm) Coated Tube Radioimmunoassay KitCDX · Traditional | 04/22/1987SE |
| K860130 | Testosterone Coated Tubes Radioimmunoassay KitCDZ · Traditional | 02/19/1986SE |
| K855169 | T3 Uptake Radioimmunoassay KitKHQ · Traditional | 02/06/1986SE |
| K850254 | Parathyroid Hormone Radioimmunoassay KitCEW · Traditional | 04/03/1985SE |
| K843635 | Matched Component Set for Radioimmuno-JKC · Traditional | 09/28/1984SE |
| K841042 | Matched Component Set RadioimmunoassayCDZ · Traditional | 04/19/1984SE |
Questions and answers
When was Radioimmunoassay of No Spin(Tm) Cortisol cleared by the FDA?
Radioimmunoassay of No Spin(Tm) Cortisol (K862871) received a 510(k) decision of Substantially Equivalent on August 19, 1986, 21 days after the submission was received.
What is the product code of K862871?
The FDA product code is CGR – Radioimmunoassay, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.