hemochroma PLUS System— 510(k) K163465

Substantially Equivalent

Immunostics Inc.,

FDA 510(k) clearance K163465 for hemochroma PLUS System, Substantially Equivalent on 2017-09-08. Applicant: Immunostics Inc.,.

Clearance details

Applicant: Immunostics Inc.,
Product code: Code GKR
Advisory panel: Hematology
Date received: 2016-12-12
Decision date: 2017-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ocean, NJ, US

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