Cleared Traditional

Stat Profile Prime Plus Analyzer System

K180186 · Nova Biomedical Corporation · Chemistry
Aug 2018
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K180186 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 August 23, 2018, 212 days after receiving the submission on January 23, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K180186 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2018
Decision Date August 23, 2018
Days to Decision 212 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code GGZ — Oxyhemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7500