Cleared Traditional

Stat Profile Prime Plus Analyzer System

K221900 · Nova Biomedical Corporation · Chemistry
Sep 2023
Decision
456d
Days
Class 2
Risk

About This 510(k) Submission

K221900 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 September 29, 2023, 456 days after receiving the submission on June 30, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K221900 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2022
Decision Date September 29, 2023
Days to Decision 456 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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