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FDA 510(k)

LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS

K-Number: K800106 · 1980-02-13

ApplicantRadioimmunoassay, Inc.
Decision Date1980-02-13
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS is the device name listed in this FDA 510(k) record. The listed applicant is Radioimmunoassay, Inc.. It received FDA 510(k) clearance on 1980-02-13 under 510(k) number K800106. 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 SYS?

LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS is a medical device that received FDA 510(k) clearance on 1980-02-13. The listed applicant is Radioimmunoassay, Inc.. The 510(k) number is K800106.

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

LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS received FDA 510(k) clearance on 1980-02-13, under 510(k) number K800106.

Who is the listed applicant for LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS?

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

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

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

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Other records listing Radioimmunoassay, Inc. as applicant

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Related Devices (Code: 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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