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FDA 510(k)

CMV ANTIGEN CONTROL SLIDES

K-Number: K964875 · 1997-03-18

ApplicantViral Antigens, Inc.
Decision Date1997-03-18
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV ANTIGEN CONTROL SLIDES is the device name listed in this FDA 510(k) record. The listed applicant is Viral Antigens, Inc.. It received FDA 510(k) clearance on 1997-03-18 under 510(k) number K964875. 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 CMV ANTIGEN CONTROL SLIDES?

CMV ANTIGEN CONTROL SLIDES is a medical device that received FDA 510(k) clearance on 1997-03-18. The listed applicant is Viral Antigens, Inc.. The 510(k) number is K964875.

When did CMV ANTIGEN CONTROL SLIDES receive FDA 510(k) clearance?

CMV ANTIGEN CONTROL SLIDES received FDA 510(k) clearance on 1997-03-18, under 510(k) number K964875.

Who is the listed applicant for CMV ANTIGEN CONTROL SLIDES?

The FDA 510(k) record lists Viral Antigens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMV ANTIGEN CONTROL SLIDES?

The FDA product code for CMV ANTIGEN CONTROL SLIDES is GQH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Viral Antigens, 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.

K964874HSV-1 ANTIGEN CONTROL SLIDESK971101HSV-2 ANTIGEN CONTROL SLIDESK964870RSV ANTIGEN CONTROL SLIDESK964872VZV ANTIGEN CONTROL SLIDESK903882VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG

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.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.K880679BION CMV-G TEST SYSTEMBion Ent., Ltd.

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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