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FDA 510(k)

RIANEN LUTEINIZING HORMONE RIA KIT

K-Number: K833376 · 1983-12-20

ApplicantNew England Nuclear
Decision Date1983-12-20
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIANEN LUTEINIZING HORMONE RIA 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 1983-12-20 under 510(k) number K833376. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIANEN LUTEINIZING HORMONE RIA KIT?

RIANEN LUTEINIZING HORMONE RIA KIT is a medical device that received FDA 510(k) clearance on 1983-12-20. The listed applicant is New England Nuclear. The 510(k) number is K833376.

When did RIANEN LUTEINIZING HORMONE RIA KIT receive FDA 510(k) clearance?

RIANEN LUTEINIZING HORMONE RIA KIT received FDA 510(k) clearance on 1983-12-20, under 510(k) number K833376.

Who is the listed applicant for RIANEN LUTEINIZING HORMONE RIA 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 LUTEINIZING HORMONE RIA KIT?

The FDA product code for RIANEN LUTEINIZING HORMONE RIA KIT is CEP.

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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 RADIOIMMUNOASSAYK840301RIANEN ESTRIOL RADIOIMMUNOASSAY KITK834038RIANEN FOLLICLE STIMULATING HORMONEK831345RIANEN PROLACTIN 125I KITK801245ATOMLIGHT (LIQUID SCINTILLATION SOLUTIONK792175RIANEN, VITAMIN B12 ASSAY SYSTEM

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Related Devices (Code: CEP)

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.

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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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