Synermed Opiate Enzyme Immunoassay— 510(k) K172416

Name: FDA 510(k) clearance K172416
Creator: U.S. Food and Drug Administration
Published: 2018-04-19

Substantially Equivalent

Infrared Laboratory Systems, LLC (Dba Synermed)

FDA 510(k) clearance K172416 for Synermed Opiate Enzyme Immunoassay, Substantially Equivalent on 2018-04-19. Applicant: Infrared Laboratory Systems, LLC (Dba Synermed). Device class: 2.

Clearance details

Applicant: Infrared Laboratory Systems, LLC (Dba Synermed)
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2017-08-10
Decision date: 2018-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westfield, IN, US

Download summary PDF View on FDA.gov ↗

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