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FDA 510(k)

VARICELLA ZOSTER VIRUS

K-Number: K894622 · 1989-10-24

ApplicantBion Ent., Ltd.
Decision Date1989-10-24
Product CodeGQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VARICELLA ZOSTER VIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Bion Ent., Ltd.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K894622. The device is classified under product code GQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARICELLA ZOSTER VIRUS?

VARICELLA ZOSTER VIRUS is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K894622.

When did VARICELLA ZOSTER VIRUS receive FDA 510(k) clearance?

VARICELLA ZOSTER VIRUS received FDA 510(k) clearance on 1989-10-24, under 510(k) number K894622.

Who is the listed applicant for VARICELLA ZOSTER VIRUS?

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

What is the FDA product code for VARICELLA ZOSTER VIRUS?

The FDA product code for VARICELLA ZOSTER VIRUS is GQW.

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Other records listing Bion Ent., 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.

K926066BION MUMPS-G ANTIBODY TEST SYSTEMK901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDEK894624MUMPS VIRUSK894623RESPIRATORY SYNCYTIAL VIRUSK894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGENK891785BION EBV-G (VCA) TEST SYSTEM

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Related Devices (Code: GQW)

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.

K070206DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000Diagnostic Hybrids, Inc.K990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295Light DiagnosticsK964872VZV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K942743VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENTViro Research, Inc.K912239VZVSCAN(TM) LATEX AGGUTINATION TESTBd Becton Dickinson Vacutainer Systems PreanalyticK903882VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGGViral Antigens, 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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