Phase II Cortisol Kit
FDA 510(k) K834219 · Medical & Scientific Designs, Inc.
510(k) numberK834219
Submission
- Device name
- Phase II Cortisol Kit
- Applicant
- Medical & Scientific Designs, Inc.
Mchenry, IL, US - Received
- December 5, 1983
- Decision date
- February 4, 1984
- 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 |
|---|---|---|
| K862960 | Phase II Ferritin Radioimmunoassay KitDBF · Traditional | 08/27/1986SE |
| K853224 | Phase II B-12/FOLATE KitCDD · Traditional | 10/03/1985SE |
| K840901 | Phase II Free T4 KitCEC · Traditional | 04/25/1984SE |
| K840328 | Phase II HCG KitJHI · Traditional | 04/19/1984SE |
| K833789 | Phase II Theophylline RadioimmunoassayLCA · Traditional | 01/24/1984SE |
| K832499 | Phase II TSH KitJLW · Traditional | 09/12/1983SE |
| K832210 | Gamma Photon Gamma CounterJJJ · Traditional | 08/24/1983SE |
| K832209 | Kineti Count 24 Gamma CounterJJJ · Traditional | 08/24/1983SE |
| K831064 | Phase II T3 Radioimmunoassay KitCDP · Traditional | 05/09/1983SE |
| K830900 | Uptake T3 Radioimmunoassay KitKHQ · Traditional | 04/18/1983SE |
Questions and answers
When was Phase II Cortisol Kit cleared by the FDA?
Phase II Cortisol Kit (K834219) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 61 days after the submission was received.
What is the product code of K834219?
The FDA product code is CGR – Radioimmunoassay, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.