GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS— 510(k) K121433

Clearance details

Applicant

Hmd Biomedical, Inc.

Product code

Code LFR

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2012-05-14

Decision date

2013-02-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Xinpu Township, Hsinchu County, TW

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Death

3

Malfunction

1,634

Total

1,637

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 →