Cleared Traditional

GEM Premier ChemSTAT

K183555 · Instrumentation Laboratory CO · Chemistry
Feb 2019
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K183555 is an FDA 510(k) clearance for the GEM Premier ChemSTAT, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on February 16, 2019, 58 days after receiving the submission on December 20, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K183555 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2018
Decision Date February 16, 2019
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFY — Enzymatic Method, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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