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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173624
510(k) Type
Traditional
Applicant
Origio a/s
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
3/2/2018
Days to Decision
98 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173624
510(k) Type
Traditional
Applicant
Origio a/s
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
3/2/2018
Days to Decision
98 days
Submission Type
Summary