510(k) K021646

BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK by Binax, Inc. — Product Code PSZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 19, 2002
Date Received: May 20, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Devices Detecting Influenza A, B, And C Virus Antigens
Device Class: Class II
Regulation Number: 866.3328
Review Panel: MI
Submission Type

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

Other clearances by Binax, Inc.

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K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (February 24, 2010)
K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST (December 16, 2009)
K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-430 (September 4, 2009)
K083744 — BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (September 1, 2009)
K092223 — MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST (August 12, 2009)
K080003 — BINAXNOW G6PD TEST (October 23, 2008)
K062109 — BINAXNOW INFLUENZA A & B TEST (November 9, 2006)
K053126 — BINAXNOW INFLUENZA A & B TEST (November 30, 2005)
K041049 — BINAXNOW INFLUENZA A & B TEST (August 10, 2004)

Other clearances for product code PSZ

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K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit (December 5, 2023)
K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (January 27, 2023)
K192719 — Osom Ultra Plus Flu A&B Test Kit (April 3, 2020)
K191514 — CareStart Flu A&B Plus (February 18, 2020)
K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
K182157 — BioSign Flu A+B (September 18, 2018)
K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader (August 8, 2018)