Cleared Traditional

Atellica CH Amylase_2 (AMY_2)

K191454 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Jul 2019
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K191454 is an FDA 510(k) clearance for the Atellica CH Amylase_2 (AMY_2), a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on July 30, 2019, 60 days after receiving the submission on May 31, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K191454 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2019
Decision Date July 30, 2019
Days to Decision 60 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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