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FDA 510(k)

SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI

K-Number: K883670 · 1989-04-28

ApplicantElectro-Nucleonics, Inc.
Decision Date1989-04-28
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics, Inc.. It received FDA 510(k) clearance on 1989-04-28 under 510(k) number K883670. 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 SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI?

SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI is a medical device that received FDA 510(k) clearance on 1989-04-28. The listed applicant is Electro-Nucleonics, Inc.. The 510(k) number is K883670.

When did SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI receive FDA 510(k) clearance?

SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI received FDA 510(k) clearance on 1989-04-28, under 510(k) number K883670.

Who is the listed applicant for SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI?

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

What is the FDA product code for SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI?

The FDA product code for SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI is GNP.

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Other records listing Electro-Nucleonics, Inc. as applicant

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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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