Cleared Traditional

Stat Profile Prime ES Comp Plus Analyzer System

K191365 · Nova Biomedical Corporation · Chemistry
Jul 2019
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K191365 is an FDA 510(k) clearance for the Stat Profile Prime ES Comp Plus Analyzer System, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on July 19, 2019, 58 days after receiving the submission on May 22, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K191365 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2019
Decision Date July 19, 2019
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

Similar Devices — JGS Electrode, Ion Specific, Sodium

All 160
i-STAT CG8+ cartridge with the i-STAT 1 System
K230275 · Abbott Point of Care, Inc. · Oct 2023
A-LYTE? Integrated Multisensor (IMT Na K Cl)
K222438 · Siemens Healthcare Diagnostics, Inc. · Jul 2023
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
K220977 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Jul 2023
GLP systems Track
K213486 · Abbott Laboratories · Mar 2022
Stat Profile Prime Plus Analyzer System
K200403 · Nova Biomedical Corporation · Apr 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688 · Abbott Point of Care, Inc. · Feb 2020