NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN— 510(k) K102441

Name: FDA 510(k) clearance K102441
Creator: U.S. Food and Drug Administration
Published: 2010-10-20

Substantially Equivalent

Nano-Ditech Corporation

FDA 510(k) clearance K102441 for NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN, Substantially Equivalent on 2010-10-20. Applicant: Nano-Ditech Corporation. Device class: 2.

Clearance details

Applicant: Nano-Ditech Corporation
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2010-07-29
Decision date: 2010-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Cranbury, NJ, 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

More clearances from Nano-Ditech Corporation

view all

K252283 — Nano-Check Influenza A+B Test2026-01-15
K243561 — Nano-Check Influenza+COVID-19 Dual Test2025-06-17
K240280 — Nano-Check RSV Test2024-07-30
K231187 — Nano-Check COVID-19 Antigen Test2024-01-23
K102131 — NANO-CHECK AMI CTNI CARDIAC MARKER TEST2010-10-20

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.