Cleared Traditional

Stat Profile Prime Plus Analyzer System

K200204 · Nova Biomedical Corporation · Chemistry

Apr 2020

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K200204 is an FDA 510(k) clearance for the Stat Profile Prime Plus Analyzer System, a Oxyhemoglobin (Class II — Special Controls, product code GGZ), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on April 6, 2020, 69 days after receiving the submission on January 28, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number	K200204 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2020
Decision Date	April 06, 2020
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF