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FDA 510(k)

RSV ANTIGEN CONTROL SLIDES

K-Number: K964870 · 1997-03-18

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

Device Summary

RSV 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 K964870. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSV ANTIGEN CONTROL SLIDES?

RSV 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 K964870.

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

RSV ANTIGEN CONTROL SLIDES received FDA 510(k) clearance on 1997-03-18, under 510(k) number K964870.

Who is the listed applicant for RSV 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 RSV ANTIGEN CONTROL SLIDES?

The FDA product code for RSV ANTIGEN CONTROL SLIDES is GQG.

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 SLIDESK964872VZV ANTIGEN CONTROL SLIDESK964875CMV ANTIGEN CONTROL SLIDESK903882VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG

Related Devices (Code: GQG)

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.

K253318Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd.K240280Nano-Check™ RSV TestNano-Ditech CorporationK162911Sofia RSV FIA on Sofia 2 analyzerQuidel CorporationK133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVBecton, Dickinson & COK132456BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSVBecton, Dickinson and CompanyK130398SOFIA(R) RSV FIAQuidel Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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