Amylase2— 510(k) K210633

Substantially Equivalent

Abbott Ireland Diagnostics Division

FDA 510(k) clearance K210633 for Amylase2, Substantially Equivalent on 2022-05-26. Applicant: Abbott Ireland Diagnostics Division.

Clearance details

Applicant: Abbott Ireland Diagnostics Division
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 2021-03-03
Decision date: 2022-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longsford, IE

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