Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer— 510(k) K153692

Name: FDA 510(k) clearance K153692
Creator: U.S. Food and Drug Administration
Published: 2016-06-24

Substantially Equivalent

Infrared Laboratory Systems, LLC (Dba Synermed)

FDA 510(k) clearance K153692 for Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer, Substantially Equivalent on 2016-06-24. Applicant: Infrared Laboratory Systems, LLC (Dba Synermed). Device class: 2.

Clearance details

Applicant: Infrared Laboratory Systems, LLC (Dba Synermed)
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2015-12-23
Decision date: 2016-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westfield, IN, 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 Infrared Laboratory Systems, LLC (Dba Synermed)

view all

K181201 — Synermed ISE Reagents2018-07-10
K172416 — Synermed Opiate Enzyme Immunoassay2018-04-19

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.