DeviceClearance

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

Substantially Equivalent

Focus Diagnostics

FDA 510(k) clearance K150962 for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack, Substantially Equivalent on 2015-08-28. Applicant: Focus Diagnostics.

Clearance details

Applicant
Focus Diagnostics
Product code
Code OQO
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cypress, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.