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FDA 510(k)

EBV(EPSTEIN-BARR VIRUS) TEST KIT

K-Number: K854207 · 1986-04-24

ApplicantImmuno-Diagnostic Products, Inc.
Decision Date1986-04-24
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV(EPSTEIN-BARR VIRUS) TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Diagnostic Products, Inc.. It received FDA 510(k) clearance on 1986-04-24 under 510(k) number K854207. 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(EPSTEIN-BARR VIRUS) TEST KIT?

EBV(EPSTEIN-BARR VIRUS) TEST KIT is a medical device that received FDA 510(k) clearance on 1986-04-24. The listed applicant is Immuno-Diagnostic Products, Inc.. The 510(k) number is K854207.

When did EBV(EPSTEIN-BARR VIRUS) TEST KIT receive FDA 510(k) clearance?

EBV(EPSTEIN-BARR VIRUS) TEST KIT received FDA 510(k) clearance on 1986-04-24, under 510(k) number K854207.

Who is the listed applicant for EBV(EPSTEIN-BARR VIRUS) TEST KIT?

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

What is the FDA product code for EBV(EPSTEIN-BARR VIRUS) TEST KIT?

The FDA product code for EBV(EPSTEIN-BARR VIRUS) TEST KIT is GNP.

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Other records listing Immuno-Diagnostic Products, Inc. as applicant

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.

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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.K020707EBV-EBNA IGG ELISA KIT, MODEL EBG-100Pan Bio Pty. , Ltd.K020717EBV V VCA IGM ELISA KIT MODEL# EBM-200Pan Bio Pty. , Ltd.K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMDiamedix Corp.K981831IS EBV-EA-D 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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