IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5— 510(k) K991795

Clearance details

Applicant

Diagnostic Products Corp.

Product code

Code MMI

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

1999-05-26

Decision date

1999-06-09

Decision

Substantially Equivalent

Clearance type

Special

Location

Los Angeles, CA, US

• 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

• K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN2006-12-05
• K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I2004-01-21
• K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER2003-12-12
• K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE2003-10-10
• K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE2002-12-17

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 →

• Z-0801-2015 — Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20141027

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991795.