ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)— 510(k) K173624

Substantially Equivalent

Origio A/S

FDA 510(k) clearance K173624 for ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311), Substantially Equivalent on 2018-03-02. Applicant: Origio A/S.

Clearance details

Applicant
Origio A/S
Product code
Code MQL
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Måløv, DK
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Data sourced from openFDA. This site is unofficial and independent of the FDA.