FDA 510(k)

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

K-Number: K032166 · 2003-10-21

Decision Date2003-10-21

Product CodeGQG

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 2003-10-21 under 510(k) number K032166. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 is a medical device that received FDA 510(k) clearance on 2003-10-21. The listed applicant is Binax, Inc.. The 510(k) number is K032166.

When did BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 receive FDA 510(k) clearance?

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 received FDA 510(k) clearance on 2003-10-21, under 510(k) number K032166.

Who is the listed applicant for BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065?

The FDA 510(k) record lists Binax, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065?

The FDA product code for BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 is GQG.

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Other records listing Binax, Inc. as applicant

K090301BINAXNOW PBP2A TEST, MODEL 890-000 K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 K090964BINAXNOX STAPHYLOCOCCUS AUREUS TEST K091489CLEARVIEW ADVANCED STREP A , MODEL 737-430 K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 K092223MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

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Related Devices (Code: GQG)

K253318Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd.K240280Nano-Check™ RSV TestNano-Ditech Corporation K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation K133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVBecton, Dickinson & CO K132456BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSVBecton, Dickinson and Company K130398SOFIA(R) RSV FIAQuidel Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.