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FDA 510(k)

EBV-VCA ANTIBODY (IGG)

K-Number: K884591 · 1989-01-24

ApplicantHillcrest Biologicals
Decision Date1989-01-24
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV-VCA ANTIBODY (IGG) is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1989-01-24 under 510(k) number K884591. 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-VCA ANTIBODY (IGG)?

EBV-VCA ANTIBODY (IGG) is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Hillcrest Biologicals. The 510(k) number is K884591.

When did EBV-VCA ANTIBODY (IGG) receive FDA 510(k) clearance?

EBV-VCA ANTIBODY (IGG) received FDA 510(k) clearance on 1989-01-24, under 510(k) number K884591.

Who is the listed applicant for EBV-VCA ANTIBODY (IGG)?

The FDA 510(k) record lists Hillcrest Biologicals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBV-VCA ANTIBODY (IGG)?

The FDA product code for EBV-VCA ANTIBODY (IGG) is GNP.

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Other records listing Hillcrest Biologicals 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.

K913618ARBOVIRUS IGM IFA TESTK913617ARBOVIRUS IGG IFA TESTK913906Q FEVER IGG IFA TESTK922374Q FEVER IGM IFA TESTK900206LYME DISEASE IGM ELISAK896594EBV VCA ANTIBODY (IGM)

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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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