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FDA 510(k)

IMAGEN INFLUENZA VIRUS A AND B TESTMI

K-Number: K872958 · 1988-02-24

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1988-02-24
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMAGEN INFLUENZA VIRUS A AND B TESTMI is the device name listed in this FDA 510(k) record. The listed applicant is Boots-Celltech Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-02-24 under 510(k) number K872958. 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 IMAGEN INFLUENZA VIRUS A AND B TESTMI?

IMAGEN INFLUENZA VIRUS A AND B TESTMI is a medical device that received FDA 510(k) clearance on 1988-02-24. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K872958.

When did IMAGEN INFLUENZA VIRUS A AND B TESTMI receive FDA 510(k) clearance?

IMAGEN INFLUENZA VIRUS A AND B TESTMI received FDA 510(k) clearance on 1988-02-24, under 510(k) number K872958.

Who is the listed applicant for IMAGEN INFLUENZA VIRUS A AND B TESTMI?

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

What is the FDA product code for IMAGEN INFLUENZA VIRUS A AND B TESTMI?

The FDA product code for IMAGEN INFLUENZA VIRUS A AND B TESTMI is GNX.

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Other records listing Boots-Celltech Diagnostics, Inc. as applicant

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K871877IDEIA HERPES SIMPLEX VIRUS TESTK880799MODIFIED IDEIA CHLAMYDIA TESTK880758SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAYK874875CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)K872843OVEIA (TM) DUAL ANALYTEK873625CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)

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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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