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FDA 510(k)

EBV V VCA IGM ELISA KIT MODEL# EBM-200

K-Number: K020717 · 2002-06-13

ApplicantPan Bio Pty. , Ltd.
Decision Date2002-06-13
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV V VCA IGM ELISA KIT MODEL# EBM-200 is the device name listed in this FDA 510(k) record. The listed applicant is Pan Bio Pty. , Ltd.. It received FDA 510(k) clearance on 2002-06-13 under 510(k) number K020717. 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 V VCA IGM ELISA KIT MODEL# EBM-200?

EBV V VCA IGM ELISA KIT MODEL# EBM-200 is a medical device that received FDA 510(k) clearance on 2002-06-13. The listed applicant is Pan Bio Pty. , Ltd.. The 510(k) number is K020717.

When did EBV V VCA IGM ELISA KIT MODEL# EBM-200 receive FDA 510(k) clearance?

EBV V VCA IGM ELISA KIT MODEL# EBM-200 received FDA 510(k) clearance on 2002-06-13, under 510(k) number K020717.

Who is the listed applicant for EBV V VCA IGM ELISA KIT MODEL# EBM-200?

The FDA 510(k) record lists Pan Bio Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBV V VCA IGM ELISA KIT MODEL# EBM-200?

The FDA product code for EBV V VCA IGM ELISA KIT MODEL# EBM-200 is GNP.

Related Clinical Trials

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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Other records listing Pan Bio Pty. , Ltd. 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.

K021793EBV EA-D IGG ELISA KIT, MODEL EBG-100K020706EBV-VCA IGG ELISA TEST, MODEL EBG-100K020707EBV-EBNA IGG ELISA KIT, MODEL EBG-100

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.

K020707EBV-EBNA IGG ELISA KIT, MODEL EBG-100Pan Bio Pty. , Ltd.K020706EBV-VCA IGG ELISA TEST, MODEL EBG-100Pan 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.K883670SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIElectro-Nucleonics, 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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