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FDA 510(k)

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer

K-Number: K153692 · 2016-06-24

ApplicantInfrared Laboratory Systems, LLC (Dba Synermed)
Decision Date2016-06-24
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer is a medical device manufactured by Infrared Laboratory Systems, LLC (Dba Synermed). It received FDA 510(k) clearance on 2016-06-24 under approval number K153692. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer?

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Infrared Laboratory Systems, LLC (Dba Synermed). The 510(k) number is K153692.

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

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer received FDA 510(k) clearance on 2016-06-24, under approval number K153692.

What company makes Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer?

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer is manufactured by Infrared Laboratory Systems, LLC (Dba Synermed).

What is the FDA product code for Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer?

The FDA product code for Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer is CGA.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED

Other Devices by Infrared Laboratory Systems, LLC (Dba Synermed)

K181201Synermed ISE Reagents K172416Synermed Opiate Enzyme Immunoassay

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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