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510(k) K190807

VITROS XT Chemistry Products TBIL-ALKP Slides by Ortho-Clinical Diagnostics, Inc. — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2019
Date Received
March 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo Colorimetry, Bilirubin
Device Class
Class II
Regulation Number
862.1110
Review Panel
CH
Submission Type

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