CAPTIA MEASLES IGM— 510(k) K140455

Substantially Equivalent

Trinity Biotech USA

FDA 510(k) clearance K140455 for CAPTIA MEASLES IGM, Substantially Equivalent on 2014-05-22. Applicant: Trinity Biotech USA. Device class: 1.

Clearance details

Applicant: Trinity Biotech USA
Product code: Code PCL
Device class: Class 1
Regulation: 21 CFR 866.3520
Advisory panel: Microbiology
Date received: 2014-02-24
Decision date: 2014-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, NY, US

Download summary PDF View on FDA.gov ↗

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K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM2003-11-26
K033064 — MYCOPLASMA IGG2003-11-26
K033067 — PYLORI IGG2003-11-26

Recalls naming K140455

K-number listed on FDA's recall record

Z-1503-2021 — Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.Class II·Terminated·Clark Laboratories, Inc.·20210317
Z-2782-2016 — Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVDClass III·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·20160711

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140455.

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