Cleared Traditional

Amylase2

K210633 · Abbott Ireland Diagnostics Division · Chemistry
May 2022
Decision
449d
Days
Class 2
Risk

About This 510(k) Submission

K210633 is an FDA 510(k) clearance for the Amylase2, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Abbott Ireland Diagnostics Division (Longsford, IE). The FDA issued a Cleared decision on May 26, 2022, 449 days after receiving the submission on March 3, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K210633 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2021
Decision Date May 26, 2022
Days to Decision 449 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFJ — Catalytic Methods, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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