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510(k) K183099

QUANTIEN Measurement System by St. Jude Medical (Now Abbott Medical) — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2019
Date Received
November 7, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by St. Jude Medical (Now Abbott Medical)

  • K183320 — Ilumien Optis, Optis Integrated, Optis Mobile (April 2, 2019)

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