CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN— 510(k) K051925

Clearance details

Applicant

Access Bio Incorporate

Product code

Code MMI

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

2005-07-18

Decision date

2005-11-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Monmouth Jct., NJ, US

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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 →