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FDA 510(k)

VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES

K-Number: K971494 · 1997-09-10

ApplicantZymetx, Inc.
Decision Date1997-09-10
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B 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 1997-09-10 under 510(k) number K971494. The device is classified under product code GNX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES?

VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES is a medical device that received FDA 510(k) clearance on 1997-09-10. The listed applicant is Zymetx, Inc.. The 510(k) number is K971494.

When did VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES receive FDA 510(k) clearance?

VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES received FDA 510(k) clearance on 1997-09-10, under 510(k) number K971494.

Who is the listed applicant for VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B 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 INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES?

The FDA product code for VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES is GNX.

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.

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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 VIRUSESK950838VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES

Related Devices (Code: GNX)

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.

K133411ALERE BINAXNOW INFLUENZA A & B CARDAlere Scarborough, Inc D/B/A Binax, Inc.K132352SAS FLUALERT A & B, SAS INFLUENZA A TESTSa Scientific , Ltd.K131804REMEL XPECT FLU A&BRemel, Inc.K131599QUICK VUE INFLUENZAQuidel CorporationK131606SOFIA INFLUENZA A+B FIAQuidel Corp.K131619QUICKVUE INFLUENZA A+BQuidel 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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