Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CISBIO RENIN RIA TEST

K-Number: K062120 · 2007-03-30

ApplicantCis Bio International
Decision Date2007-03-30
Product CodeCIB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CISBIO RENIN RIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Cis Bio International. It received FDA 510(k) clearance on 2007-03-30 under 510(k) number K062120. The device is classified under product code CIB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CISBIO RENIN RIA TEST?

CISBIO RENIN RIA TEST is a medical device that received FDA 510(k) clearance on 2007-03-30. The listed applicant is Cis Bio International. The 510(k) number is K062120.

When did CISBIO RENIN RIA TEST receive FDA 510(k) clearance?

CISBIO RENIN RIA TEST received FDA 510(k) clearance on 2007-03-30, under 510(k) number K062120.

Who is the listed applicant for CISBIO RENIN RIA TEST?

The FDA 510(k) record lists Cis Bio International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CISBIO RENIN RIA TEST?

The FDA product code for CISBIO RENIN RIA TEST is CIB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: CIB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123763IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERSImmunodiagnostic Systems , Ltd.K121944LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENTDiaSorin, Inc.K061758ACTIVE RENIN IRMADiagnostic Systems Laboratories, Inc.K011128NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)Nichols Institute DiagnosticsK981607ACTIVE RENIN IRMA MODEL NUMBER DSL-25100Diagnostic Systems Laboratories, Inc.K954299BUHLMANN ANGIOSTENSIN II RIABuhlmann Laboratories AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑