GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)— 510(k) K160402

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

2016-02-12

Decision date

2016-12-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bedford, MA, US

• K252488 — ABL90 FLEX PLUS System2026-05-01
• K210933 — YSI 2900C Biochemistry Analyzer2024-09-30
• K220328 — EasyStat 3002024-07-26
• K223179 — Cholestech LDX System2023-09-20
• K223755 — i-STAT G cartridge with the i-STAT 1 System2023-09-11

• K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM2023-09-29
• K223187 — HemosIL Liquid Anti-Xa2023-06-23
• K223090 — GEM Premier ChemSTAT2023-01-27
• K223402 — HemosIL von Willebrand Factor Antigen2022-12-09
• K213464 — HemosIL Liquid Anti-Xa2022-10-04

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 →