Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer

FDA 510(k) K153692 · Infrared Laboratory Systems, LLC (Dba Synermed)

Substantially Equivalent

510(k) numberK153692

Submission

Device name
Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
Applicant
Infrared Laboratory Systems, LLC (Dba Synermed)
Westfield, IN, US
Received
December 23, 2015
Decision date
June 24, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CGA – Glucose Oxidase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

Other 510(k)s with product code CGA

510(k)DeviceApplicantDecision
K252488ABL90 FLEX PLUS SystemCGA · Traditional Radiometer Medicals Aps05/01/2026SE
K210933YSI 2900C Biochemistry AnalyzerCGA · Traditional Ysi, Inc.09/30/2024SE
K220328EasyStat 300CGA · Traditional Medica Corporation07/26/2024SE
K223179Cholestech LDX ™ SystemCGA · Dual Track Alere San Diego, Inc.09/20/2023SE
K223755i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.09/11/2023SE
K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.07/28/2023SE
K223090GEM Premier ChemSTATCGA · Special Instrumentation Laboratory CO01/27/2023SE
K203549Nova Primary Glucose Analyzer SystemCGA · Traditional Nova Biomedical Corporation10/18/2022SE
K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.08/13/2021SE
K200349Stat Profile Prime Plus Analyzer SystemCGA · Traditional Nova Biomedical Corporation03/13/2020SE

More from Nova Biomedical Corporation

510(k)DeviceDecision
K181201Synermed ISE ReagentsJGS · Traditional 07/10/2018SE
K172416Synermed Opiate Enzyme ImmunoassayDJG · Traditional 04/19/2018SE

Questions and answers

When was Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer cleared by the FDA?

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer (K153692) received a 510(k) decision of Substantially Equivalent on June 24, 2016, 184 days after the submission was received.

What is the product code of K153692?

The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.