Cleared Traditional

Stat Profile Prime ES Comp Plus Analyzer System

K191626 · Nova Biomedical Corporation · Chemistry
Aug 2019
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K191626 is an FDA 510(k) clearance for the Stat Profile Prime ES Comp Plus Analyzer System, a Electrode, Ion Specific, Calcium (Class II — Special Controls, product code JFP), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on August 16, 2019, 59 days after receiving the submission on June 18, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K191626 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2019
Decision Date August 16, 2019
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFP — Electrode, Ion Specific, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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