Active Renin Immunoradiometric Assay
FDA 510(k) K925998 · Nichols Institute Diagnostics
510(k) numberK925998
Submission
- Device name
- Active Renin Immunoradiometric Assay
- Applicant
- Nichols Institute Diagnostics
San Juan Capistrano, CA, US - Received
- November 27, 1992
- Decision date
- January 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CIB – Radioimmunoassay, Angiotensin I And Renin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1085
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123763 | Ids Isys Direct Renin Assay, Ids Isys Direct Renin Control Set, and Ids Isys Direct…CIB · Traditional | Immunodiagnostic Systems , Ltd. | 12/24/2013SE |
| K121944 | Liaison Direct Renin Liaison Control Direct Renin Liaison Endocrinology DiluentCIB · Traditional | DiaSorin, Inc. | 01/01/2013SE |
| K062120 | Cisbio Renin Ria TestCIB · Traditional | Cis Bio International | 03/30/2007SE |
| K061758 | Active Renin IrmaCIB · Special | Diagnostic Systems Laboratories, Inc. | 07/28/2006SE |
| K011128 | Nichols Advantage Direct Renin (Calibrators, Calibration Verifiers, Controls, and Sample…CIB · Traditional | Nichols Institute Diagnostics | 09/06/2001SE |
| K981607 | Active Renin Irma Model Number DSL-25100CIB · Traditional | Diagnostic Systems Laboratories, Inc. | 05/27/1998SE |
| K954299 | Buhlmann Angiostensin II RiaCIB · Traditional | Buhlmann Laboratories AG | 10/19/1995SE |
| K940004 | Ai-PhotodiagnosticCIB · Traditional | Pharmarceutical Discovery Corp. | 08/04/1995SE |
| K850054 | Rianen Angiotensin I Radioimmunoassay KiCIB · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/29/1985SE |
| K842966 | Renin Radioimmunoassay Test KitCIB · Traditional | Serono Diagnostics, Inc. | 10/11/1984SE |
More from Serono Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K050784 | Nichols Advantage Aldosterone AssayCJM · Traditional | 06/01/2005SE |
| 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 |
Questions and answers
When was Active Renin Immunoradiometric Assay cleared by the FDA?
Active Renin Immunoradiometric Assay (K925998) received a 510(k) decision of Substantially Equivalent on January 6, 1993, 40 days after the submission was received.
What is the product code of K925998?
The FDA product code is CIB – Radioimmunoassay, Angiotensin I And Renin, a Class II (moderate risk) device regulated under 21 CFR 862.1085.