MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST— 510(k) K092223

Name: FDA 510(k) clearance K092223
Creator: U.S. Food and Drug Administration
Published: 2009-08-12

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K092223 for MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST, Substantially Equivalent on 2009-08-12. Applicant: Binax, Inc.. Device class: 2.

Clearance details

Applicant: Binax, Inc.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2009-07-23
Decision date: 2009-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PSZ

view all

K254262 — Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA2026-09-04
K252283 — Nano-Check Influenza A+B Test2026-01-15
K250398 — Innovita Flu A/B Antigen Rapid Test2025-07-03
K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System2025-04-18
K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit2023-12-05

More clearances from Binax, Inc.

view all

K090301 — BINAXNOW PBP2A TEST, MODEL 890-0002010-04-14
K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-0002010-02-24
K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST2009-12-16
K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-4302009-09-04
K083744 — BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-0102009-09-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.