FilmArray NGDS Warrior Panel

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

BioFire Defense, LLC

The following data is part of a premarket notification filed by Biofire Defense, Llc with the FDA for Filmarray Ngds Warrior Panel.

Pre-market Notification Details

• Device ID: K170883
• 510k Number: K170883
• Device Name: FilmArray NGDS Warrior Panel
• Classification: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
• Applicant: BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City, UT 84107
• Contact: Cynthia Phillips
• Correspondent: Cynthia Phillips; BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City, UT 84107
• Product Code: PRD
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-24
• Decision Date: 2017-06-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851458005136	K170883	000