Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES

K-Number: K950838 · 1996-06-17

ApplicantZymetx, Inc.
Decision Date1996-06-17
Product CodeGNT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES is the device name listed in this FDA 510(k) record. The listed applicant is Zymetx, Inc.. It received FDA 510(k) clearance on 1996-06-17 under 510(k) number K950838. The device is classified under product code GNT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES?

VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES is a medical device that received FDA 510(k) clearance on 1996-06-17. The listed applicant is Zymetx, Inc.. The 510(k) number is K950838.

When did VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES receive FDA 510(k) clearance?

VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES received FDA 510(k) clearance on 1996-06-17, under 510(k) number K950838.

Who is the listed applicant for VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES?

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

What is the FDA product code for VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES?

The FDA product code for VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES is GNT.

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 Zymetx, 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.

K984596VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIESK982429ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSESK971494VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES

Related Devices (Code: GNT)

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.

K913828QTEST INFLUENZA ABd Becton Dickinson Vacutainer Systems PreanalyticK902609DIRECTIGEN FLU ABd Becton Dickinson Vacutainer Systems PreanalyticK780275INFLUENZA HA ANTIGEN A/USSRFlow Laboratories, Inc.K780272INFLUENZA HA ANTIGENFlow Laboratories, 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.

↑