Osom Ultra Plus Flu A&B Test Kit— 510(k) K192719

Clearance details

Applicant

SEKISUI Diagnostics, LLC

Product code

Code PSZ

Device class

Class 2

Regulation

21 CFR 866.3328

Advisory panel

Microbiology

Date received

2019-09-26

Decision date

2020-04-03

Decision

Substantially Equivalent

Clearance type

Dual Track

Location

San Diego, CA, US

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