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FDA 510(k)

ACTIVE RENIN IMMUNORADIOMETRIC ASSAY

K-Number: K925998 · 1993-01-06

ApplicantNichols Institute Diagnostics
Decision Date1993-01-06
Product CodeCIB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTIVE RENIN IMMUNORADIOMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1993-01-06 under 510(k) number K925998. 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 IMMUNORADIOMETRIC ASSAY?

ACTIVE RENIN IMMUNORADIOMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1993-01-06. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K925998.

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

ACTIVE RENIN IMMUNORADIOMETRIC ASSAY received FDA 510(k) clearance on 1993-01-06, under 510(k) number K925998.

Who is the listed applicant for ACTIVE RENIN IMMUNORADIOMETRIC ASSAY?

The FDA 510(k) record lists Nichols Institute Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTIVE RENIN IMMUNORADIOMETRIC ASSAY?

The FDA product code for ACTIVE RENIN IMMUNORADIOMETRIC ASSAY is CIB.

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Other records listing Nichols Institute Diagnostics as applicant

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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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 InternationalK061758ACTIVE 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.

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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