DeviceClearance

Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack— 510(k) K143651

Substantially Equivalent

Focus Diagnostics, Inc.

FDA 510(k) clearance K143651 for Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack, Substantially Equivalent on 2015-03-18. Applicant: Focus Diagnostics, Inc..

Clearance details

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

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