XPECT FLU A & B— 510(k) K092423

Clearance details

Applicant

Thermo Fisher Scientific

Product code

Code PSZ

Device class

Class 2

Regulation

21 CFR 866.3328

Advisory panel

Microbiology

Date received

2009-08-07

Decision date

2009-08-26

Decision

Substantially Equivalent

Clearance type

Special

Location

Lenexa, KS, US

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