Renin Radioimmunoassay Test Kit
FDA 510(k) K842966 · Serono Diagnostics, Inc.
510(k) numberK842966
Submission
- Device name
- Renin Radioimmunoassay Test Kit
- Applicant
- Serono Diagnostics, Inc.
Bramtree, MA, US - Received
- July 27, 1984
- Decision date
- October 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIB – Radioimmunoassay, Angiotensin I And Renin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1085
- Specialty
- Clinical Chemistry
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| K062120 | Cisbio Renin Ria TestCIB · Traditional | Cis Bio International | 03/30/2007SE |
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| 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 |
| K925998 | Active Renin Immunoradiometric AssayCIB · Traditional | Nichols Institute Diagnostics | 01/06/1993SE |
| K850054 | Rianen Angiotensin I Radioimmunoassay KiCIB · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/29/1985SE |
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Questions and answers
When was Renin Radioimmunoassay Test Kit cleared by the FDA?
Renin Radioimmunoassay Test Kit (K842966) received a 510(k) decision of Substantially Equivalent on October 11, 1984, 76 days after the submission was received.
What is the product code of K842966?
The FDA product code is CIB – Radioimmunoassay, Angiotensin I And Renin, a Class II (moderate risk) device regulated under 21 CFR 862.1085.