Liaison Direct Renin Liaison Control Direct Renin Liaison Endocrinology Diluent
FDA 510(k) K121944 · DiaSorin, Inc.
510(k) numberK121944
Submission
- Device name
- Liaison Direct Renin Liaison Control Direct Renin Liaison Endocrinology Diluent
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- July 3, 2012
- Decision date
- January 1, 2013
- 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 |
| 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 |
| 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 |
| K842966 | Renin Radioimmunoassay Test KitCIB · Traditional | Serono Diagnostics, Inc. | 10/11/1984SE |
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Questions and answers
When was Liaison Direct Renin Liaison Control Direct Renin Liaison Endocrinology Diluent cleared by the FDA?
Liaison Direct Renin Liaison Control Direct Renin Liaison Endocrinology Diluent (K121944) received a 510(k) decision of Substantially Equivalent on January 1, 2013, 182 days after the submission was received.
What is the product code of K121944?
The FDA product code is CIB – Radioimmunoassay, Angiotensin I And Renin, a Class II (moderate risk) device regulated under 21 CFR 862.1085.