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FDA 510(k)

INFLUENZA HA ANTIGEN

K-Number: K780272 · 1978-02-28

ApplicantFlow Laboratories, Inc.
Decision Date1978-02-28
Product CodeGNT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INFLUENZA HA ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1978-02-28 under 510(k) number K780272. 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 INFLUENZA HA ANTIGEN?

INFLUENZA HA ANTIGEN is a medical device that received FDA 510(k) clearance on 1978-02-28. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K780272.

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

INFLUENZA HA ANTIGEN received FDA 510(k) clearance on 1978-02-28, under 510(k) number K780272.

Who is the listed applicant for INFLUENZA HA ANTIGEN?

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

What is the FDA product code for INFLUENZA HA ANTIGEN?

The FDA product code for INFLUENZA HA ANTIGEN is GNT.

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Other records listing Flow Laboratories, Inc. as applicant

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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.

K950838VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSESZymetx, Inc.K913828QTEST INFLUENZA ABd Becton Dickinson Vacutainer Systems PreanalyticK902609DIRECTIGEN FLU ABd Becton Dickinson Vacutainer Systems PreanalyticK780275INFLUENZA HA ANTIGEN A/USSRFlow 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.

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