Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack— 510(k) K150962

Clearance details

Applicant

Focus Diagnostics

Product code

Code OQO

Device class

Class 2

Regulation

21 CFR 866.3305

Advisory panel

Microbiology

Date received

2015-04-10

Decision date

2015-08-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cypress, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150962.