Stat Profile Prime ES Comp Plus Analyzer System— 510(k) K191365

Name: FDA 510(k) clearance K191365
Creator: U.S. Food and Drug Administration
Published: 2019-07-19

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K191365 for Stat Profile Prime ES Comp Plus Analyzer System, Substantially Equivalent on 2019-07-19. Applicant: Nova Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 2019-05-22
Decision date: 2019-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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 →

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