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FDA 510(k)

RENIN RADIOIMMUNOASSAY TEST KIT

K-Number: K842966 · 1984-10-11

ApplicantSerono Diagnostics, Inc.
Decision Date1984-10-11
Product CodeCIB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RENIN RADIOIMMUNOASSAY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-10-11 under 510(k) number K842966. 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 RENIN RADIOIMMUNOASSAY TEST KIT?

RENIN RADIOIMMUNOASSAY TEST KIT is a medical device that received FDA 510(k) clearance on 1984-10-11. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K842966.

When did RENIN RADIOIMMUNOASSAY TEST KIT receive FDA 510(k) clearance?

RENIN RADIOIMMUNOASSAY TEST KIT received FDA 510(k) clearance on 1984-10-11, under 510(k) number K842966.

Who is the listed applicant for RENIN RADIOIMMUNOASSAY TEST KIT?

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

What is the FDA product code for RENIN RADIOIMMUNOASSAY TEST KIT?

The FDA product code for RENIN RADIOIMMUNOASSAY TEST KIT is CIB.

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Other records listing Serono Diagnostics, Inc. 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.

K953598SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERSK942051SR1 DHEA-S ENZYME IMMUNOASSAYK883085T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHASK882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHAK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

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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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