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FDA 510(k)

INFLUENZA A2 VIRUS

K-Number: K843659 · 1985-09-26

ApplicantInstitute Virion , Ltd.
Decision Date1985-09-26
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INFLUENZA A2 VIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Institute Virion , Ltd.. It received FDA 510(k) clearance on 1985-09-26 under 510(k) number K843659. 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 INFLUENZA A2 VIRUS?

INFLUENZA A2 VIRUS is a medical device that received FDA 510(k) clearance on 1985-09-26. The listed applicant is Institute Virion , Ltd.. The 510(k) number is K843659.

When did INFLUENZA A2 VIRUS receive FDA 510(k) clearance?

INFLUENZA A2 VIRUS received FDA 510(k) clearance on 1985-09-26, under 510(k) number K843659.

Who is the listed applicant for INFLUENZA A2 VIRUS?

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

What is the FDA product code for INFLUENZA A2 VIRUS?

The FDA product code for INFLUENZA A2 VIRUS is GNX.

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Other records listing Institute Virion , 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.

K862814COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNIK843662MEASLES VIRUS RUBEOLAK843660IN FLUENZA B VIRUSK843657CYTOMEGALOVIRUSK843658H. SIMPLEX VIRUSK843673RESPIRATORY SYNCYTIAL VIRUS

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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

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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