FILMARRAY RESPIRATORY PANEL (RP)

Respiratory Virus Panel Nucleic Acid Assay System

IDAHO TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Idaho Technology, Inc. with the FDA for Filmarray Respiratory Panel (rp).

Pre-market Notification Details

• Device ID: K103175
• 510k Number: K103175
• Device Name: FILMARRAY RESPIRATORY PANEL (RP)
• Classification: Respiratory Virus Panel Nucleic Acid Assay System
• Applicant: IDAHO TECHNOLOGY, INC. 390 Wakara Way Salt Lake City, UT 84108
• Contact: Beth Lingenfelter
• Correspondent: Beth Lingenfelter; IDAHO TECHNOLOGY, INC. 390 Wakara Way Salt Lake City, UT 84108
• Product Code: OCC
• Subsequent Product Code: NXD
• Subsequent Product Code: OEM
• Subsequent Product Code: OEP
• Subsequent Product Code: OOU
• Subsequent Product Code: OTG
• CFR Regulation Number: 866.3980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-10-28
• Decision Date: 2011-02-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815381020024	K103175	000
00815381020017	K103175	000
00851458005112	K103175	000