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FDA 510(k)

Synermed Opiate Enzyme Immunoassay

K-Number: K172416 · 2018-04-19

ApplicantInfrared Laboratory Systems, LLC (Dba Synermed)
Decision Date2018-04-19
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Synermed Opiate Enzyme Immunoassay is a medical device manufactured by Infrared Laboratory Systems, LLC (Dba Synermed). It received FDA 510(k) clearance on 2018-04-19 under approval number K172416. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synermed Opiate Enzyme Immunoassay?

Synermed Opiate Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2018-04-19. It is manufactured by Infrared Laboratory Systems, LLC (Dba Synermed). The 510(k) number is K172416.

When was Synermed Opiate Enzyme Immunoassay approved by the FDA?

Synermed Opiate Enzyme Immunoassay received FDA 510(k) clearance on 2018-04-19, under approval number K172416.

What company makes Synermed Opiate Enzyme Immunoassay?

Synermed Opiate Enzyme Immunoassay is manufactured by Infrared Laboratory Systems, LLC (Dba Synermed).

What is the FDA product code for Synermed Opiate Enzyme Immunoassay?

The FDA product code for Synermed Opiate Enzyme Immunoassay is DJG.

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

K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer K181201Synermed ISE Reagents

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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.

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