510(k) K131804

Device: REMEL XPECT FLU A&B
Applicant: REMEL, INC.
510(k) number: K131804
Product code: GNX
Decision: Substantially Equivalent (SESE)
Decision date: 2013-07-12
Date received: 2013-06-19
Regulation: 866.3330
Classification name: Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K133411	ALERE BINAXNOW INFLUENZA A & B CARD	Alere Scarborough, Inc D/B/A Binax, Inc.	2013-12-05
K132352	SAS FLUALERT A & B, SAS INFLUENZA A TEST	Sa Scientific , Ltd.	2013-08-22
K131599	QUICK VUE INFLUENZA	Quidel Corporation	2013-07-05
K131606	SOFIA INFLUENZA A+B FIA	Quidel Corp.	2013-07-05
K131619	QUICKVUE INFLUENZA A+B	Quidel Corp.	2013-06-28
K123182	OSOM INFLUENZA A&B TEST MODEL 190	SEKISUI Diagnostics, LLC	2012-11-05
K971494	VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES	Zymetx, Inc.	1997-09-10
K924006	BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY	Baxter Healthcare Corp	1992-12-29
K901493	FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B	Whittaker Bioproducts, Inc.	1990-06-27
K893579	FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A	Whittaker Bioproducts, Inc.	1990-01-16
K884191	INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION	Baxter Diagnostics, Inc.	1988-11-22
K872958	IMAGEN INFLUENZA VIRUS A AND B TESTMI	Boots-Celltech Diagnostics, Inc.	1988-02-24
K871231	ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B	Microscan Div. Baxter Healthcare Corp.	1987-06-26
K871233	ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A	Microscan Div. Baxter Healthcare Corp.	1987-06-26
K843659	INFLUENZA A2 VIRUS	Institute Virion , Ltd.	1985-09-26

summary

Decision Summary