Cleared Abbreviated

Multichem IA Plus

K162530 · Techno-Path Manufacturing · Chemistry
Mar 2017
Decision
203d
Days
Class 1
Risk

About This 510(k) Submission

K162530 is an FDA 510(k) clearance for the Multichem IA Plus, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Techno-Path Manufacturing (Co. Tipperary, IE). The FDA issued a Cleared decision on March 31, 2017, 203 days after receiving the submission on September 9, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K162530 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2016
Decision Date March 31, 2017
Days to Decision 203 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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