AIA-PACK TROPONIN I ASSAY— 510(k) K984359

Name: FDA 510(k) clearance K984359
Creator: U.S. Food and Drug Administration
Published: 1998-12-23

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K984359 for AIA-PACK TROPONIN I ASSAY, Substantially Equivalent on 1998-12-23. Applicant: Tosoh Medics, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1998-12-07
Decision date: 1998-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, 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 Tosoh Medics, Inc.

view all

K023893 — ST AIA-PACK CEA ENZYME IMMUNOASSAY2002-12-18
K023091 — ST AIA-PACK TESTOSTERONE ASSAY2002-12-17
K023894 — ST AIA-PACK AFP ENZYME IMMUNOASSAY2002-12-17
K023891 — ST AIA-PACK CA 125 ENZYME IMMUNOASSAY2002-12-06
K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE2002-05-14

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.