Pancoat Cortisol Coated Tube Radioimmunoassay Kit
FDA 510(k) K862336 · Pantex, Div. Bio-Analysis, Inc.
510(k) numberK862336
Submission
- Device name
- Pancoat Cortisol Coated Tube Radioimmunoassay Kit
- Applicant
- Pantex, Div. Bio-Analysis, Inc.
Santa Monica, CA, US - Received
- June 20, 1986
- Decision date
- September 25, 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 |
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| K912804 | FSH Irma ImmunomagCGJ · Traditional | 08/12/1991SE |
| K911839 | Neonatal Blood Spot Test 17-HYDROXPROG Radio KitJLX · Traditional | 06/18/1991SE |
| K911050 | LH Irma ImmunomagCEP · Traditional | 04/12/1991SE |
| K910717 | Pantex Irma LH 1251 KitCEP · Traditional | 03/19/1991SE |
| K894049 | Immunocoat Progesterone Radioimmunoassay KitJLS · Traditional | 09/08/1989SE |
| K862483 | Pantex Fte Free Testosterone Radioimmunoassay KitCDZ · Traditional | 01/14/1987SE |
| K862447 | Pancoat T3 Uptake Coated Tube Radioimmunoassay KitKHQ · Traditional | 10/07/1986SE |
Questions and answers
When was Pancoat Cortisol Coated Tube Radioimmunoassay Kit cleared by the FDA?
Pancoat Cortisol Coated Tube Radioimmunoassay Kit (K862336) received a 510(k) decision of Substantially Equivalent on September 25, 1986, 97 days after the submission was received.
What is the product code of K862336?
The FDA product code is CGR – Radioimmunoassay, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.