FDA 510(k)

XPECT FLU A & B

K-Number: K092423 · 2009-08-26

Decision Date2009-08-26

Product CodePSZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

XPECT FLU A & B is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific. It received FDA 510(k) clearance on 2009-08-26 under 510(k) number K092423. 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 FLU A & B?

XPECT FLU A & B is a medical device that received FDA 510(k) clearance on 2009-08-26. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K092423.

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

XPECT FLU A & B received FDA 510(k) clearance on 2009-08-26, under 510(k) number K092423.

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

The FDA 510(k) record lists Thermo Fisher Scientific as the applicant. This does not by itself establish the device manufacturer.

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

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.