MULTISTAT III GLUCOSE TEST— 510(k) K771471

Name: FDA 510(k) clearance K771471
Creator: U.S. Food and Drug Administration
Published: 1977-09-12

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K771471 for MULTISTAT III GLUCOSE TEST, Substantially Equivalent on 1977-09-12. Applicant: Instrumentation Laboratory CO. Device class: 2.

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: 1977-08-04
Decision date: 1977-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGA

view all

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

More clearances from Instrumentation Laboratory CO

view all

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

Adverse events under product code CGA

product code CGA

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.