Cleared Traditional

Ammonia II

K183517 · Roche Diagnostics Operations (Rdo) · Chemistry
Feb 2019
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K183517 is an FDA 510(k) clearance for the Ammonia II, a Enzymatic Method, Ammonia (Class I — General Controls, product code JIF), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on February 8, 2019, 52 days after receiving the submission on December 18, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K183517 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2018
Decision Date February 08, 2019
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIF — Enzymatic Method, Ammonia
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1065

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