Cortisol Clasp-Bead Eia Kit
FDA 510(k) K895407 · Biotecx Laboratories, Inc.
510(k) numberK895407
Submission
- Device name
- Cortisol Clasp-Bead Eia Kit
- Applicant
- Biotecx Laboratories, Inc.
Friendswood, TX, US - Received
- September 6, 1989
- Decision date
- October 19, 1989
- 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 |
|---|---|---|
| K982298 | Opticoat T4 Eia KitKLI · Traditional | 02/03/1999SE |
| K981824 | Opticoat T3 Eia KitCDP · Traditional | 12/22/1998SE |
| K893620 | T3 Clasp-Bead Eia KitCDP · Traditional | 08/11/1989SE |
| K892853 | T4 Clasp-Bead Eia KitKLI · Traditional | 05/22/1989SE |
| K883765 | TBG 125I Ria Kit, Radioimmuno. of Serum ThyroxineKHQ · Traditional | 10/31/1988SE |
| K871211 | Progesterone Clasp Radioimmunoassay KitJLS · Traditional | 04/13/1987SE |
| K863188 | HPL Ria KitJMX · Traditional | 09/25/1986SE |
| K854876 | Aldosterone Direct Ria KitKQN · Traditional | 03/17/1986SE |
| K851540 | Estradiol Direct Ria KitCHP · Traditional | 06/06/1985SE |
| K844767 | Radioimmunoassay of Human Serum Plasma or Urine toCGI · Traditional | 02/01/1985SE |
Questions and answers
When was Cortisol Clasp-Bead Eia Kit cleared by the FDA?
Cortisol Clasp-Bead Eia Kit (K895407) received a 510(k) decision of Substantially Equivalent on October 19, 1989, 43 days after the submission was received.
What is the product code of K895407?
The FDA product code is CGR – Radioimmunoassay, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.