Renak

FDA 510(k) K831694 · Hoffmann-La Roche, Inc.

Substantially Equivalent

510(k) numberK831694

Submission

Device name
Renak
Applicant
Hoffmann-La Roche, Inc.
Mchenry, IL, US
Received
May 24, 1983
Decision date
July 19, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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)DeviceApplicantDecision
K123763Ids Isys Direct Renin Assay, Ids Isys Direct Renin Control Set, and Ids Isys Direct…CIB · Traditional Immunodiagnostic Systems , Ltd.12/24/2013SE
K121944Liaison Direct Renin Liaison Control Direct Renin Liaison Endocrinology DiluentCIB · Traditional DiaSorin, Inc.01/01/2013SE
K062120Cisbio Renin Ria TestCIB · Traditional Cis Bio International03/30/2007SE
K061758Active Renin IrmaCIB · Special Diagnostic Systems Laboratories, Inc.07/28/2006SE
K011128Nichols Advantage Direct Renin (Calibrators, Calibration Verifiers, Controls, and Sample…CIB · Traditional Nichols Institute Diagnostics09/06/2001SE
K981607Active Renin Irma Model Number DSL-25100CIB · Traditional Diagnostic Systems Laboratories, Inc.05/27/1998SE
K954299Buhlmann Angiostensin II RiaCIB · Traditional Buhlmann Laboratories AG10/19/1995SE
K940004Ai-PhotodiagnosticCIB · Traditional Pharmarceutical Discovery Corp.08/04/1995SE
K925998Active Renin Immunoradiometric AssayCIB · Traditional Nichols Institute Diagnostics01/06/1993SE
K850054Rianen 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)DeviceDecision
K850727Bhcg-Roche EiaJHI · Traditional 06/25/1985SE
K830482Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional 03/24/1983SE
K830481Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional 03/24/1983SE
K830480Abuscreen Radioimmunoassay-Cocaine MetaKLN · Traditional 03/24/1983SE
K830462Abuscreen Radioummunoassay--UrineDOE · Traditional 03/24/1983SE
K830461Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional 03/24/1983SE
K830460Abuscreen Radioimmunoassay for MorphineDOE · Traditional 03/24/1983SE
K830479Abuscreen Radioimmunoassay-BarbiturateDKN · Traditional 03/10/1983SE
K823580Cobas Reagent for Inorganic PhosphorusCEO · Traditional 01/07/1983SE
K823579Cobas Reagent for Total ProteinCEK · Traditional 01/07/1983SE

Questions and answers

When was Renak cleared by the FDA?

Renak (K831694) received a 510(k) decision of Substantially Equivalent on July 19, 1983, 56 days after the submission was received.

What is the product code of K831694?

The FDA product code is CIB – Radioimmunoassay, Angiotensin I And Renin, a Class II (moderate risk) device regulated under 21 CFR 862.1085.