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FDA 510(k)

REMEL XPECT FLU A&B

K-Number: K131804 · 2013-07-12

ApplicantRemel, Inc.
Decision Date2013-07-12
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REMEL XPECT FLU A&B is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 2013-07-12 under 510(k) number K131804. 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 REMEL XPECT FLU A&B?

REMEL XPECT FLU A&B is a medical device that received FDA 510(k) clearance on 2013-07-12. The listed applicant is Remel, Inc.. The 510(k) number is K131804.

When did REMEL XPECT FLU A&B receive FDA 510(k) clearance?

REMEL XPECT FLU A&B received FDA 510(k) clearance on 2013-07-12, under 510(k) number K131804.

Who is the listed applicant for REMEL XPECT FLU A&B?

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

What is the FDA product code for REMEL XPECT FLU A&B?

The FDA product code for REMEL XPECT FLU A&B is GNX.

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Other records listing Remel, 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.

K162620Remel Spectra ESBLK092407REMEL SPECTRA MRSAK072827RPMI 1640 AGAR W/MOPS AND 2% GLUCOSEK041951XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BK033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYK031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

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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.K131606SOFIA INFLUENZA A+B FIAQuidel Corp.K131599QUICK VUE INFLUENZAQuidel CorporationK131619QUICKVUE INFLUENZA A+BQuidel Corp.K123182OSOM INFLUENZA A&B TEST MODEL 190SEKISUI Diagnostics, LLC

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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