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FDA 510(k)

ACTIVE RENIN IRMA

K-Number: K061758 · 2006-07-28

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date2006-07-28
Product CodeCIB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTIVE RENIN IRMA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 2006-07-28 under 510(k) number K061758. 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 ACTIVE RENIN IRMA?

ACTIVE RENIN IRMA is a medical device that received FDA 510(k) clearance on 2006-07-28. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K061758.

When did ACTIVE RENIN IRMA receive FDA 510(k) clearance?

ACTIVE RENIN IRMA received FDA 510(k) clearance on 2006-07-28, under 510(k) number K061758.

Who is the listed applicant for ACTIVE RENIN IRMA?

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

What is the FDA product code for ACTIVE RENIN IRMA?

The FDA product code for ACTIVE RENIN IRMA is CIB.

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Other records listing Diagnostic Systems Laboratories, Inc. as applicant

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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.K062120CISBIO RENIN RIA TESTCis Bio InternationalK011128NICHOLS 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.

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