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FDA 510(k)

GEMENI IGA ASSAY

K-Number: K800449 · 1980-03-12

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1980-03-12
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GEMENI IGA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800449. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMENI IGA ASSAY?

GEMENI IGA ASSAY is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K800449.

When did GEMENI IGA ASSAY receive FDA 510(k) clearance?

GEMENI IGA ASSAY received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800449.

Who is the listed applicant for GEMENI IGA ASSAY?

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

What is the FDA product code for GEMENI IGA ASSAY?

The FDA product code for GEMENI IGA ASSAY is CZP.

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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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