FDA 510(k)

IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS

K-Number: K123763 · 2013-12-24

ApplicantImmunodiagnostic Systems , Ltd.

Decision Date2013-12-24

Product CodeCIB

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2013-12-24 under 510(k) number K123763. 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 IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS?

IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS is a medical device that received FDA 510(k) clearance on 2013-12-24. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K123763.

When did IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS receive FDA 510(k) clearance?

IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS received FDA 510(k) clearance on 2013-12-24, under 510(k) number K123763.

Who is the listed applicant for IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS?

The FDA 510(k) record lists Immunodiagnostic Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS?

The FDA product code for IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS is CIB.

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Related Devices (Code: CIB)

K121944LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENTDiaSorin, Inc.K062120CISBIO RENIN RIA TESTCis Bio International K061758ACTIVE RENIN IRMADiagnostic Systems Laboratories, Inc.K011128NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)Nichols Institute Diagnostics K981607ACTIVE 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.