Hemosure Accu-Reader A100— 510(k) K200754

Substantially Equivalent

W.H.P.M., Inc.

FDA 510(k) clearance K200754 for Hemosure Accu-Reader A100, Substantially Equivalent on 2022-06-02. Applicant: W.H.P.M., Inc..

Clearance details

Applicant: W.H.P.M., Inc.
Product code: Code OOX
Advisory panel: Hematology
Date received: 2020-03-23
Decision date: 2022-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irwindale, CA, US

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