NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM— 510(k) K131703

Name: FDA 510(k) clearance K131703
Creator: U.S. Food and Drug Administration
Published: 2014-03-25

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K131703 for NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM, Substantially Equivalent on 2014-03-25. Applicant: Nova Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 2013-06-11
Decision date: 2014-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHL

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K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
K240998 — ABL90 FLEX PLUS System2024-12-13
K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

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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

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K131703

K-number listed on FDA's recall record

Z-2732-2017 — Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry AnalyzerClass II·Terminated·Nova Biomedical Corporation·20170619

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131703.

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