FDA 510(k)

Synermed ISE Reagents

Número K: K181201 · 2018-07-10

RequerenteInfrared Laboratory Systems, LLC (Dba Synermed)

Data da decisão2018-07-10

Código do produtoJGS

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Synermed ISE Reagents 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 2018-07-10 under 510(k) number K181201. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Synermed ISE Reagents?

Synermed ISE Reagents is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Infrared Laboratory Systems, LLC (Dba Synermed). The 510(k) number is K181201.

When did Synermed ISE Reagents receive FDA 510(k) clearance?

Synermed ISE Reagents received FDA 510(k) clearance on 2018-07-10, under 510(k) number K181201.

Who is the listed applicant for Synermed ISE Reagents?

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 ISE Reagents?

The FDA product code for Synermed ISE Reagents is JGS.

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Outros registros que listam Infrared Laboratory Systems, LLC (Dba Synermed) como candidato(a)

K172416Synermed Opiate Enzyme Immunoassay K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer

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