PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2— 510(k) K100130

Name: FDA 510(k) clearance K100130
Creator: U.S. Food and Drug Administration
Published: 2011-05-16

Substantially Equivalent

Mitsubishi Chemical Medience CO

FDA 510(k) clearance K100130 for PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2, Substantially Equivalent on 2011-05-16. Applicant: Mitsubishi Chemical Medience CO. Device class: 2.

Clearance details

Applicant: Mitsubishi Chemical Medience CO
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2010-01-19
Decision date: 2011-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baldwin, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MMI

view all

K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System2026-06-11
K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack2025-10-29
K243483 — Access hsTnI2025-08-01
K242870 — Access hsTnI2025-06-16
K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System2025-01-03

Adverse events under product code MMI

product code MMI

Injury: 172
Malfunction: 3,762
Total: 3,934

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.