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FDA 510(k)

LUTEINIZING HORMONE DIRECT RIA KIT 125/I

K-Number: K811024 · 1981-05-08

ApplicantImmunalysis Corporation
Decision Date1981-05-08
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUTEINIZING HORMONE DIRECT RIA KIT 125/I is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 1981-05-08 under 510(k) number K811024. 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 DIRECT RIA KIT 125/I?

LUTEINIZING HORMONE DIRECT RIA KIT 125/I is a medical device that received FDA 510(k) clearance on 1981-05-08. The listed applicant is Immunalysis Corporation. The 510(k) number is K811024.

When did LUTEINIZING HORMONE DIRECT RIA KIT 125/I receive FDA 510(k) clearance?

LUTEINIZING HORMONE DIRECT RIA KIT 125/I received FDA 510(k) clearance on 1981-05-08, under 510(k) number K811024.

Who is the listed applicant for LUTEINIZING HORMONE DIRECT RIA KIT 125/I?

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

What is the FDA product code for LUTEINIZING HORMONE DIRECT RIA KIT 125/I?

The FDA product code for LUTEINIZING HORMONE DIRECT RIA KIT 125/I 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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