SAFEPICO— 510(k) K043143

Clearance details

Applicant

Radiometer Medical Aps

Product code

Code JKA

Device class

Class 2

Regulation

21 CFR 862.1675

Advisory panel

Clinical Chemistry

Date received

2004-11-15

Decision date

2005-04-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bronshoj, DK

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Injury

455

Malfunction

26,686

Other

4

Total

27,145

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 →