FDA 510(k)

INFLUENZA B ANITGEN TEST

K-Number: K942174 · 1994-06-30

Decision Date1994-06-30

Product CodeGNW

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

INFLUENZA B ANITGEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Neogenex. It received FDA 510(k) clearance on 1994-06-30 under 510(k) number K942174. The device is classified under product code GNW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFLUENZA B ANITGEN TEST?

INFLUENZA B ANITGEN TEST is a medical device that received FDA 510(k) clearance on 1994-06-30. The listed applicant is Neogenex. The 510(k) number is K942174.

When did INFLUENZA B ANITGEN TEST receive FDA 510(k) clearance?

INFLUENZA B ANITGEN TEST received FDA 510(k) clearance on 1994-06-30, under 510(k) number K942174.

Who is the listed applicant for INFLUENZA B ANITGEN TEST?

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

What is the FDA product code for INFLUENZA B ANITGEN TEST?

The FDA product code for INFLUENZA B ANITGEN TEST is GNW.

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Related Devices (Code: GNW)

K092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.K092300MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.K081746D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.K061101D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.K022713DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.K003204BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KITIntracel 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.