HemoCue Hb 801 System— 510(k) K181751

Substantially Equivalent

Hemocue AB

FDA 510(k) clearance K181751 for HemoCue Hb 801 System, Substantially Equivalent on 2019-02-01. Applicant: Hemocue AB.

Clearance details

Applicant: Hemocue AB
Product code: Code GKR
Advisory panel: Hematology
Date received: 2018-07-02
Decision date: 2019-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ängelholm, SE

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