IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)— 510(k) K022158

Clearance details

Applicant

Instrumentation Laboratory CO

Product code

Code CGA

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2002-07-02

Decision date

2002-09-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bedford, MA, US

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Death

2

Malfunction

1,816

Total

1,818

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 →