Nichols Advantage Aldosterone Assay
FDA 510(k) K050784 · Nichols Institute Diagnostics
510(k) numberK050784
Submission
- Device name
- Nichols Advantage Aldosterone Assay
- Applicant
- Nichols Institute Diagnostics
San Clemente, CA, US - Received
- March 28, 2005
- Decision date
- June 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- CJM – Radioimmunoassay, Aldosterone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1045
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…CJM · Traditional | Immunodiagnostic Systems , Ltd. | 04/21/2015SE |
| K130321 | Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration…CJM · Traditional | Diasorin | 04/09/2013SE |
| K032188 | Nichols Advantage Aldosterone AssayCJM · Traditional | Nichols Institute Diagnostics | 07/31/2003SE |
| K943397 | DSL Active Aldosterone Ria (DSL 8600)CJM · Traditional | Diagnostic Systems Laboratories, Inc. | 02/13/1995SE |
| K921205 | DSL Active Aldosterone (DSL 8600)CJM · Traditional | Diagnostic Systems Laboratories, Inc. | 07/10/1992SE |
| K862204 | RSL (125I) Aldosterone KitCJM · Traditional | Radioassay Systems Laboratories, Inc. | 09/25/1986SE |
| K834428 | Aldosterone Radioimmunoassay Test KitCJM · Traditional | Serono Laboratories, Inc. | 03/02/1984SE |
| K831178 | Coat-A-Count No-Extraction AldosteroneCJM · Traditional | Diagnostic Products Corp. | 05/27/1983SE |
| K800775 | ALDOCTK-125CJM · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 04/21/1980SE |
| K781504 | 125I-ALDOSTERONE Ria Diag. KitCJM · Traditional | Abbott Laboratories | 11/22/1978SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K042676 | Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) AssayDHA · Traditional | 12/17/2004SE |
| K042689 | Nichols Advantage CortisolCGR · Traditional | 12/09/2004SE |
| K040813 | Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022CEW · Traditional | 06/08/2004SE |
| K033727 | Nichols Advantage Bio-Intact PTH (1-84) ImmunoassayCEW · Traditional | 04/22/2004SE |
| K033302 | Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040CEW · Special | 01/26/2004SE |
| K032188 | Nichols Advantage Aldosterone AssayCJM · Traditional | 07/31/2003SE |
| K022356 | Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies ImmunoassayLYR · Traditional | 10/25/2002SE |
| K022472 | Parathyroid Hormone Test System/Nichols Advantage Quick-Intraoperative Bio-Intact PTH…CEW · Traditional | 10/09/2002SE |
| K013992 | Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84) ImmunoassayCEW · Traditional | 12/13/2001SE |
| K012367 | Vitamin D Test System Nichols Advantage 25-HYDROXYVITAMIN DJIT · Traditional | 10/09/2001SE |
Questions and answers
When was Nichols Advantage Aldosterone Assay cleared by the FDA?
Nichols Advantage Aldosterone Assay (K050784) received a 510(k) decision of Substantially Equivalent on June 1, 2005, 65 days after the submission was received.
What is the product code of K050784?
The FDA product code is CJM – Radioimmunoassay, Aldosterone, a Class II (moderate risk) device regulated under 21 CFR 862.1045.