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FDA 510(k)

ENI ANTIBODY TO EPSTEIN-BARR VIRUS

K-Number: K810860 · 1981-05-05

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1981-05-05
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENI ANTIBODY TO EPSTEIN-BARR VIRUS 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 1981-05-05 under 510(k) number K810860. The device is classified under product code GNP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENI ANTIBODY TO EPSTEIN-BARR VIRUS?

ENI ANTIBODY TO EPSTEIN-BARR VIRUS is a medical device that received FDA 510(k) clearance on 1981-05-05. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K810860.

When did ENI ANTIBODY TO EPSTEIN-BARR VIRUS receive FDA 510(k) clearance?

ENI ANTIBODY TO EPSTEIN-BARR VIRUS received FDA 510(k) clearance on 1981-05-05, under 510(k) number K810860.

Who is the listed applicant for ENI ANTIBODY TO EPSTEIN-BARR VIRUS?

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 ENI ANTIBODY TO EPSTEIN-BARR VIRUS?

The FDA product code for ENI ANTIBODY TO EPSTEIN-BARR VIRUS is GNP.

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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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