DeviceClearance

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack— 510(k) K183223

Substantially Equivalent

Diasorin Molecular, LLC

FDA 510(k) clearance K183223 for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack, Substantially Equivalent on 2018-12-19. Applicant: Diasorin Molecular, LLC.

Clearance details

Applicant
Diasorin Molecular, LLC
Product code
Code OZZ
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Cypress, CA, US
Download summary PDFView on FDA.gov ↗

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