EPlex Respiratory Pathogen Panel

Respiratory Virus Panel Nucleic Acid Assay System

GENMARK DIAGNOSTICS, INCORPORATED

The following data is part of a premarket notification filed by Genmark Diagnostics, Incorporated with the FDA for Eplex Respiratory Pathogen Panel.

Pre-market Notification Details

• Device ID: K163636
• 510k Number: K163636
• Device Name: EPlex Respiratory Pathogen Panel
• Classification: Respiratory Virus Panel Nucleic Acid Assay System
• Applicant: GENMARK DIAGNOSTICS, INCORPORATED 5964 LA PLACE COURT Carlsbad, CA 92008
• Contact: Alan Maderazo
• Correspondent: Alan Maderazo; GENMARK DIAGNOSTICS, INCORPORATED 5964 LA PLACE COURT Carlsbad, CA 92008
• Product Code: OCC
• Subsequent Product Code: NSU
• Subsequent Product Code: OEM
• Subsequent Product Code: OEP
• Subsequent Product Code: OOU
• Subsequent Product Code: OQW
• Subsequent Product Code: OTG
• Subsequent Product Code: OZE
• Subsequent Product Code: OZX
• Subsequent Product Code: OZY
• CFR Regulation Number: 866.3980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-22
• Decision Date: 2017-06-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857167005030	K163636	000
00857167005023	K163636	000
00857167005016	K163636	000