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FDA 510(k)

EBV TEST

K-Number: K771062 · 1977-07-14

ApplicantGull Laboratories, Inc.
Decision Date1977-07-14
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K771062. 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 EBV TEST?

EBV TEST is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K771062.

When did EBV TEST receive FDA 510(k) clearance?

EBV TEST received FDA 510(k) clearance on 1977-07-14, under 510(k) number K771062.

Who is the listed applicant for EBV TEST?

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

What is the FDA product code for EBV TEST?

The FDA product code for EBV TEST is GNP.

Other records listing Gull Laboratories, Inc. as applicant

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Related Devices (Code: GNP)

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.

K020706EBV-VCA IGG ELISA TEST, MODEL EBG-100Pan Bio Pty. , Ltd.K020717EBV V VCA IGM ELISA KIT MODEL# EBM-200Pan Bio Pty. , Ltd.K020707EBV-EBNA IGG ELISA KIT, MODEL EBG-100Pan Bio Pty. , Ltd.K981831IS EBV-EA-D IGG ELISA TEST SYSTEMDiamedix Corp.K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMDiamedix Corp.K901156EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMGranbio, Inc.

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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