SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST— 510(k) K030057

Name: FDA 510(k) clearance K030057
Creator: U.S. Food and Drug Administration
Published: 2003-03-19

Substantially Equivalent

Spectral Diagnostics, Inc.

FDA 510(k) clearance K030057 for SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST, Substantially Equivalent on 2003-03-19. Applicant: Spectral Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Spectral Diagnostics, Inc.
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2003-01-07
Decision date: 2003-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

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 Spectral Diagnostics, Inc.

view all

K052519 — SPECTRAL WEST NILE VIRUS IGM STATUS TEST2006-11-30
DEN030002 — ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE2003-06-16
K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST2002-09-30
K020950 — SPECTRAL'S 2 IN 1 (TNI-MYO)2002-05-24
K014105 — SPECTRAL'S TROPONIN I2002-02-01

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.