ImmuGlo HEp-2 Elite IFA— 510(k) K172745

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K172745 for ImmuGlo HEp-2 Elite IFA, Substantially Equivalent on 2018-06-05. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code DHN
Advisory panel: Immunology
Date received: 2017-09-12
Decision date: 2018-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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