Angiotensis I-Squibb Radioimmunoassay
FDA 510(k) K820616 · E. R. Squibb & Sons, Inc.
510(k) numberK820616
Submission
- Device name
- Angiotensis I-Squibb Radioimmunoassay
- Applicant
- E. R. Squibb & Sons, Inc.
New York, NY, US - Received
- March 8, 1982
- Decision date
- March 26, 1982
- 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
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 |
| 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 |
More from E.I. Dupont DE Nemours & Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821494 | Ria Stat 16JJJ · Traditional | 06/03/1982SE |
| K820341 | Cortisol-Squibb Radioimmunoassay KitCGR · Traditional | 03/04/1982SE |
| K820340 | T3 Uptake-Squibb Diagnostic KitKHQ · Traditional | 03/04/1982SE |
| K811240 | Sur-Fit Loop Ostomy O.R. SetEXB · Traditional | 06/16/1981SE |
| K811239 | Sur-Fit Disposable Convex InsertEXB · Traditional | 06/09/1981SE |
| K811160 | Sur-Fit Irrigation SleeveEXD · Traditional | 06/02/1981SE |
| K811163 | Sur-Fit Disposable Fange CapEXB · Traditional | 05/21/1981SE |
| K810966 | Diagoxin Squibb Radioimmunoassay KitDNL · Traditional | 04/21/1981SE |
| K810211 | T3 Ria KitCDP · Traditional | 02/10/1981SE |
| K803100 | Stomahesive Paste Protective Skin BarrEZR · Traditional | 01/08/1981SE |
Questions and answers
When was Angiotensis I-Squibb Radioimmunoassay cleared by the FDA?
Angiotensis I-Squibb Radioimmunoassay (K820616) received a 510(k) decision of Substantially Equivalent on March 26, 1982, 18 days after the submission was received.
What is the product code of K820616?
The FDA product code is CIB – Radioimmunoassay, Angiotensin I And Renin, a Class II (moderate risk) device regulated under 21 CFR 862.1085.