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FDA 510(k)

RIANEN ESTRIOL RADIOIMMUNOASSAY KIT

K-Number: K840301 · 1984-03-30

ApplicantNew England Nuclear
Decision Date1984-03-30
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIANEN ESTRIOL RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is New England Nuclear. It received FDA 510(k) clearance on 1984-03-30 under 510(k) number K840301. The device is classified under product code CGI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIANEN ESTRIOL RADIOIMMUNOASSAY KIT?

RIANEN ESTRIOL RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1984-03-30. The listed applicant is New England Nuclear. The 510(k) number is K840301.

When did RIANEN ESTRIOL RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

RIANEN ESTRIOL RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1984-03-30, under 510(k) number K840301.

Who is the listed applicant for RIANEN ESTRIOL RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists New England Nuclear as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIANEN ESTRIOL RADIOIMMUNOASSAY KIT?

The FDA product code for RIANEN ESTRIOL RADIOIMMUNOASSAY KIT is CGI.

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Other records listing New England Nuclear 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.

K841478RIANEN CYCLIC-AMP RADIOIMMUNOASSAYK834038RIANEN FOLLICLE STIMULATING HORMONEK833376RIANEN LUTEINIZING HORMONE RIA KITK831345RIANEN PROLACTIN 125I KITK801245ATOMLIGHT (LIQUID SCINTILLATION SOLUTIONK792175RIANEN, VITAMIN B12 ASSAY SYSTEM

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Related Devices (Code: CGI)

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.

K974721UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K962875ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIADiagnostic Systems Laboratories, Inc.K955356ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOLDiagnostic Systems Laboratories, Inc.K932989COAT-A-COUNT FREE ESTRIOLDiagnostic Products Corp.K944490AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITWallac OYK920576AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOLEastman Kodak Company

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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