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FDA 510(k)

INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION

K-Number: K884191 · 1988-11-22

ApplicantBaxter Diagnostics, Inc.
Decision Date1988-11-22
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-11-22 under 510(k) number K884191. 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 A IFA TEST FOR DIRECT ANTIGEN DETECTION?

INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION is a medical device that received FDA 510(k) clearance on 1988-11-22. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K884191.

When did INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION receive FDA 510(k) clearance?

INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION received FDA 510(k) clearance on 1988-11-22, under 510(k) number K884191.

Who is the listed applicant for INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION?

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

What is the FDA product code for INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION?

The FDA product code for INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION is GNX.

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Other records listing Baxter Diagnostics, 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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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.K131606SOFIA INFLUENZA A+B FIAQuidel Corp.K131599QUICK VUE INFLUENZAQuidel CorporationK131619QUICKVUE 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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