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510(k) K172416

Synermed Opiate Enzyme Immunoassay by Infrared Laboratory Systems, LLC (Dba Synermed) — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2018
Date Received
August 10, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

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

  • K181201 — Synermed ISE Reagents (July 10, 2018)
  • K153692 — Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer (June 24, 2016)

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