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FDA 510(k)

RIA SYS. FOR HUMAN LUTEINIZING HORMONE

K-Number: K780367 · 1978-04-28

ApplicantCalbiochem-Behring Corp.
Decision Date1978-04-28
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA SYS. FOR HUMAN LUTEINIZING HORMONE is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1978-04-28 under 510(k) number K780367. 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 RIA SYS. FOR HUMAN LUTEINIZING HORMONE?

RIA SYS. FOR HUMAN LUTEINIZING HORMONE is a medical device that received FDA 510(k) clearance on 1978-04-28. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K780367.

When did RIA SYS. FOR HUMAN LUTEINIZING HORMONE receive FDA 510(k) clearance?

RIA SYS. FOR HUMAN LUTEINIZING HORMONE received FDA 510(k) clearance on 1978-04-28, under 510(k) number K780367.

Who is the listed applicant for RIA SYS. FOR HUMAN LUTEINIZING HORMONE?

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

What is the FDA product code for RIA SYS. FOR HUMAN LUTEINIZING HORMONE?

The FDA product code for RIA SYS. FOR HUMAN LUTEINIZING HORMONE 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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