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 the device name listed in this FDA 510(k) record. The listed applicant is Infrared Laboratory Systems, LLC (Dba Synermed). It received FDA 510(k) clearance on 2016-06-24 under 510(k) 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. The listed applicant is Infrared Laboratory Systems, LLC (Dba Synermed). The 510(k) number is K153692.

When did Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer?

The FDA 510(k) record lists Infrared Laboratory Systems, LLC (Dba Synermed) as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Infrared Laboratory Systems, LLC (Dba Synermed) as applicant

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Official Source

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