BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065

Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

BINAX, INC.

The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Now Rsv Test, Model 430-000 And Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065.

Pre-market Notification Details

• Device ID: K032166
• 510k Number: K032166
• Device Name: BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
• Classification: Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
• Applicant: BINAX, INC. 217 READ ST. Portland, ME 04103
• Contact: Pamela Angell
• Correspondent: Pamela Angell; BINAX, INC. 217 READ ST. Portland, ME 04103
• Product Code: GQG
• CFR Regulation Number: 866.3480 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-07-16
• Decision Date: 2003-10-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10811877011207	K032166	000
10811877011191	K032166	000
10811877011184	K032166	000
10811877011177	K032166	000
10811877011160	K032166	000
10811877010484	K032166	000