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FDA 510(k)

XPECT INFLUENZA A/B

K-Number: K031565 · 2003-07-17

ApplicantRemel, Inc.
Decision Date2003-07-17
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XPECT INFLUENZA 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 2003-07-17 under 510(k) number K031565. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPECT INFLUENZA A/B?

XPECT INFLUENZA A/B is a medical device that received FDA 510(k) clearance on 2003-07-17. The listed applicant is Remel, Inc.. The 510(k) number is K031565.

When did XPECT INFLUENZA A/B receive FDA 510(k) clearance?

XPECT INFLUENZA A/B received FDA 510(k) clearance on 2003-07-17, under 510(k) number K031565.

Who is the listed applicant for XPECT INFLUENZA 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 XPECT INFLUENZA A/B?

The FDA product code for XPECT INFLUENZA A/B is PSZ.

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Other records listing Remel, Inc. as applicant

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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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