FDA 510(k)

LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT

K-Number: K121944 · 2013-01-01

Decision Date2013-01-01

Product CodeCIB

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2013-01-01 under 510(k) number K121944. 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 LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT?

LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT is a medical device that received FDA 510(k) clearance on 2013-01-01. The listed applicant is DiaSorin, Inc.. The 510(k) number is K121944.

When did LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT receive FDA 510(k) clearance?

LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT received FDA 510(k) clearance on 2013-01-01, under 510(k) number K121944.

Who is the listed applicant for LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT?

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

What is the FDA product code for LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT?

The FDA product code for LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT is CIB.

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Other records listing DiaSorin, Inc. as applicant

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Related Devices (Code: CIB)

K123763IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERSImmunodiagnostic Systems , Ltd.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.