VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)— 510(k) K142033

Name: FDA 510(k) clearance K142033
Creator: U.S. Food and Drug Administration
Published: 2014-10-10

Substantially Equivalent

Nanospere,Inc.

FDA 510(k) clearance K142033 for VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP), Substantially Equivalent on 2014-10-10. Applicant: Nanospere,Inc.. Device class: 2.

Clearance details

Applicant: Nanospere,Inc.
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2014-07-25
Decision date: 2014-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K142033

K-number listed on FDA's recall record

Z-2952-2018 — Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.Class II·Terminated·Luminex Corporation·20180508

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142033.

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