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FDA 510(k)

BION CMV-G TEST SYSTEM

K-Number: K880679 · 1988-06-03

ApplicantBion Ent., Ltd.
Decision Date1988-06-03
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BION CMV-G TEST SYSTEM 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 1988-06-03 under 510(k) number K880679. The device is classified under product code GQH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BION CMV-G TEST SYSTEM?

BION CMV-G TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1988-06-03. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K880679.

When did BION CMV-G TEST SYSTEM receive FDA 510(k) clearance?

BION CMV-G TEST SYSTEM received FDA 510(k) clearance on 1988-06-03, under 510(k) number K880679.

Who is the listed applicant for BION CMV-G TEST SYSTEM?

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 BION CMV-G TEST SYSTEM?

The FDA product code for BION CMV-G TEST SYSTEM is GQH.

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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 SLIDEK894622VARICELLA ZOSTER VIRUSK894624MUMPS VIRUSK894623RESPIRATORY SYNCYTIAL VIRUSK894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN

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Related Devices (Code: GQH)

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.

K982311BARTELS CINAKIT CMV ANTIGENEMIAIntracel Corp.K964875CMV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K935809CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)Stellar Bio Systems, Inc.K882024FITC MURINE MONOCLONAL ANTI-CMV IGGWhittaker Bioproducts, Inc.K881932ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTOrtho Diagnostic Systems, 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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