GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator— 510(k) K160225

Clearance details

Applicant

Instrumentation Laboratory CO

Product code

Code JGS

Device class

Class 2

Regulation

21 CFR 862.1665

Advisory panel

Clinical Chemistry

Date received

2016-01-29

Decision date

2016-12-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bedford, MA, US

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Malfunction

535

Total

535

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 →