Active Renin Irma Model Number DSL-25100
FDA 510(k) K981607 · Diagnostic Systems Laboratories, Inc.
510(k) numberK981607
Submission
- Device name
- Active Renin Irma Model Number DSL-25100
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- May 5, 1998
- Decision date
- May 27, 1998
- 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
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|---|---|---|---|
| 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 |
| 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 |
More from Serono Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061758 | Active Renin IrmaCIB · Special | 07/28/2006SE |
| K020945 | Axsym Intact PTH, Model 2G06CEW · Traditional | 05/31/2002SE |
| K020128 | Active Free Beta-Hcg Elisa, Model DSL-10-8500JHI · Traditional | 03/01/2002SE |
| K002128 | Active Inhibin-A Elisa, Model DSL-10-28100NDR · Traditional | 12/05/2000SE |
| K001086 | Free Testosterone Enzyme Immunoassay, Model DSL-10-4900CDZ · Traditional | 05/18/2000SE |
| K990138 | DSL Active Afp Elisa, Model DSL-10-8400LOJ · Traditional | 06/21/1999SE |
| K981871 | C-Reactive Protein Elisa, Model Number DSL-10-42100DCK · Traditional | 11/09/1998SE |
| K973244 | Active Psa Irma (DSL-9700)LTJ · Traditional | 08/03/1998SE |
| K973243 | Active Psa Elisa (DSL-10-9700)LTJ · Traditional | 08/03/1998SE |
| K973514 | Active Intact PTHCEW · Traditional | 10/31/1997SE |
Questions and answers
When was Active Renin Irma Model Number DSL-25100 cleared by the FDA?
Active Renin Irma Model Number DSL-25100 (K981607) received a 510(k) decision of Substantially Equivalent on May 27, 1998, 22 days after the submission was received.
What is the product code of K981607?
The FDA product code is CIB – Radioimmunoassay, Angiotensin I And Renin, a Class II (moderate risk) device regulated under 21 CFR 862.1085.