ImmuLisa Enhanced RNA POL III Antibody ELISA— 510(k) K172078

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K172078 for ImmuLisa Enhanced RNA POL III Antibody ELISA, Substantially Equivalent on 2018-03-30. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code NYO
Advisory panel: Immunology
Date received: 2017-07-10
Decision date: 2018-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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