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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Binax, Inc. — Predicate Candidate Screening

30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

108 daysmedian FDA review time
295 days90th percentile
30clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090301BINAXNOW PBP2A TEST, MODEL 890-000Binax, Inc.2010-04-144320
K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000Binax, Inc.2010-02-242520
K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTBinax, Inc.2009-12-162540
K091489CLEARVIEW ADVANCED STREP A , MODEL 737-430Binax, Inc.2009-09-041070
K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010Binax, Inc.2009-09-012590
K092223MODIFICATION TO: BINAXNOW INFLUENZA A & B TESTBinax, Inc.2009-08-12200
K080003BINAXNOW G6PD TESTBinax, Inc.2008-10-232950
K062109BINAXNOW INFLUENZA A & B TESTBinax, Inc.2006-11-091082
K053126BINAXNOW INFLUENZA A & B TESTBinax, Inc.2005-11-30230
K041049BINAXNOW INFLUENZA A & B TESTBinax, Inc.2004-08-101100
K032166BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEBinax, Inc.2003-10-21972
K021646BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWABinax, Inc.2002-09-191220
K021649BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWABinax, Inc.2002-09-191220
K021687BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB Binax, Inc.2002-09-131140
K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.2001-11-301161
K010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ABinax, Inc.2001-03-15210
K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22Binax, Inc.1999-08-27990
K982238BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND Binax, Inc.1998-08-21571
K960712BINAX STREP A TESTBinax, Inc.1996-03-22300
K934965BINAX LEGIONELLA URINARY ANTIGEN EIABinax, Inc.1994-09-203400
K912748BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KITBinax, Inc.1991-10-311320
K903122EQUATE(TM) AQR APO AL/B DUO CONTROLBinax, Inc.1990-08-02170
K883306BINAS LUTEINIZING HORMONE IRMA TEST KITBinax, Inc.1988-10-06630
K883305BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAYBinax, Inc.1988-10-06630
K874749BINAX EQUATE GLYCOHEMOGLOBINBinax, Inc.1988-08-122680
K880218BINAX PROLACTIN IRMA DIAGNOSTIC KITBinax, Inc.1988-03-01410
K872904BINAX EQUATE STREP BBinax, Inc.1987-11-201190
K873303BINAX L.S. TSH IRMA TEST KITBinax, Inc.1987-10-02450
K872728BINAX IRMA TOTAL BETA-HCG TEST KITBinax, Inc.1987-08-05280
K863908BINAX STREP ABinax, Inc.1986-12-22760

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda