GERMCO TEST R GLUCOSE TEST KIT— 510(k) K810567

Clearance details

Applicant

Fermco Biochemics, Inc.

Product code

Code CGA

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

1981-03-03

Decision date

1981-03-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, 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

• K843832 — TRIGLYCERIDES REAGENT SYSTEM1984-11-27
• K823106 — RERMCO TEST CHLORIDE REAGENT1982-11-16
• K822117 — FERMCOTEST CO2 REAGNET1982-09-30
• K822118 — FERMCOTEST CREATININE TEST REAGENT1982-09-30
• K791066 — GLUCOSE GOD-PAP TRINDER METHOD TEST KIT1979-09-04

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 →