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FDA 510(k)

LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT

K-Number: K803278 · 1981-01-21

ApplicantImmuno Nuclear Corp.
Decision Date1981-01-21
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Nuclear Corp.. It received FDA 510(k) clearance on 1981-01-21 under 510(k) number K803278. 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 LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT?

LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1981-01-21. The listed applicant is Immuno Nuclear Corp.. The 510(k) number is K803278.

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

LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1981-01-21, under 510(k) number K803278.

Who is the listed applicant for LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT?

The FDA product code for LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT is CEP.

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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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