Stat Profile Prime ES Comp Plus Analyzer System— 510(k) K191626

Name: FDA 510(k) clearance K191626
Creator: U.S. Food and Drug Administration
Published: 2019-08-16

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K191626 for Stat Profile Prime ES Comp Plus Analyzer System, Substantially Equivalent on 2019-08-16. Applicant: Nova Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code JFP
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 2019-06-18
Decision date: 2019-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFP

view all

K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K191360 — i-STAT CHEM8+ cartridge with the i-STAT 1 System2020-02-14
K152327 — EasyLyte Na/K/Cl/Ca Analyzer2016-12-01
K984299 — AVL OPTI CRITICAL CARE ANALYZER1998-12-11
K972673 — AVL 9181 ELECTROLYTE ANALYZER1997-08-20

More clearances from Nova Biomedical Corporation

view all

K251281 — Nova Max Creat eGFR Monitoring System2026-01-21
K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer2026-01-09
K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer2024-11-22
K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer2024-11-19
K232075 — StatStrip Glucose Hospital Meter System2024-02-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.