Cleared Traditional

Stat Profile Prime Plus Analyzer System

K173797 · Nova Biomedical Corporation · Chemistry
Jul 2018
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K173797 is an FDA 510(k) clearance for the Stat Profile Prime Plus Analyzer System, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on July 17, 2018, 215 days after receiving the submission on December 14, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K173797 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2017
Decision Date July 17, 2018
Days to Decision 215 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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