Synermed ISE Reagents
K-Number: K181201 · 2018-07-10
Decision Date2018-07-10
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Synermed ISE Reagents is a medical device manufactured by Infrared Laboratory Systems, LLC (Dba Synermed). It received FDA 510(k) clearance on 2018-07-10 under approval number K181201. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Synermed ISE Reagents?
Synermed ISE Reagents is a medical device that received FDA 510(k) clearance on 2018-07-10. It is manufactured by Infrared Laboratory Systems, LLC (Dba Synermed). The 510(k) number is K181201.
When was Synermed ISE Reagents approved by the FDA?
Synermed ISE Reagents received FDA 510(k) clearance on 2018-07-10, under approval number K181201.
What company makes Synermed ISE Reagents?
Synermed ISE Reagents is manufactured by Infrared Laboratory Systems, LLC (Dba Synermed).
What is the FDA product code for Synermed ISE Reagents?
The FDA product code for Synermed ISE Reagents is JGS.
Other Devices by Infrared Laboratory Systems, LLC (Dba Synermed)
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Official Source
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