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FDA 510(k)

125-I LABELED HUMAN LUTEINIZING HORMONE

K-Number: K780576 · 1978-05-19

ApplicantPcl-Ria, Inc.
Decision Date1978-05-19
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

125-I LABELED HUMAN LUTEINIZING HORMONE is the device name listed in this FDA 510(k) record. The listed applicant is Pcl-Ria, Inc.. It received FDA 510(k) clearance on 1978-05-19 under 510(k) number K780576. 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 125-I LABELED HUMAN LUTEINIZING HORMONE?

125-I LABELED HUMAN LUTEINIZING HORMONE is a medical device that received FDA 510(k) clearance on 1978-05-19. The listed applicant is Pcl-Ria, Inc.. The 510(k) number is K780576.

When did 125-I LABELED HUMAN LUTEINIZING HORMONE receive FDA 510(k) clearance?

125-I LABELED HUMAN LUTEINIZING HORMONE received FDA 510(k) clearance on 1978-05-19, under 510(k) number K780576.

Who is the listed applicant for 125-I LABELED HUMAN LUTEINIZING HORMONE?

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

What is the FDA product code for 125-I LABELED HUMAN LUTEINIZING HORMONE?

The FDA product code for 125-I LABELED HUMAN LUTEINIZING HORMONE is CEP.

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Other records listing Pcl-Ria, Inc. 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.

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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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