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FDA 510(k)

INFLUENZA A ANTIGEN TEST

K-Number: K942172 · 1994-07-06

ApplicantNeogenex
Decision Date1994-07-06
Product CodeGNW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INFLUENZA A ANTIGEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Neogenex. It received FDA 510(k) clearance on 1994-07-06 under 510(k) number K942172. 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 A ANTIGEN TEST?

INFLUENZA A ANTIGEN TEST is a medical device that received FDA 510(k) clearance on 1994-07-06. The listed applicant is Neogenex. The 510(k) number is K942172.

When did INFLUENZA A ANTIGEN TEST receive FDA 510(k) clearance?

INFLUENZA A ANTIGEN TEST received FDA 510(k) clearance on 1994-07-06, under 510(k) number K942172.

Who is the listed applicant for INFLUENZA A ANTIGEN 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 A ANTIGEN TEST?

The FDA product code for INFLUENZA A ANTIGEN TEST is GNW.

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Other records listing Neogenex 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.

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Related Devices (Code: GNW)

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.

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.

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