Synermed ISE Reagents

FDA 510(k) K181201 · Infrared Laboratory Systems, LLC (Dba Synermed)

Substantially Equivalent

510(k) numberK181201

Submission

Device name
Synermed ISE Reagents
Applicant
Infrared Laboratory Systems, LLC (Dba Synermed)
Westfield, IN, US
Received
May 7, 2018
Decision date
July 10, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JGS – Electrode, Ion Specific, Sodium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1665
Specialty
Clinical Chemistry

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K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional Abbott Point of Care, Inc.02/07/2020SE
K191365Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional Nova Biomedical Corporation07/19/2019SE
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More from Instrumentation Laboratory CO

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Questions and answers

When was Synermed ISE Reagents cleared by the FDA?

Synermed ISE Reagents (K181201) received a 510(k) decision of Substantially Equivalent on July 10, 2018, 64 days after the submission was received.

What is the product code of K181201?

The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.