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510(k) K934965

BINAX LEGIONELLA URINARY ANTIGEN EIA by Binax, Inc. — Product Code MJH

K934965 is an FDA 510(k) premarket notification submitted by Binax, Inc. for the device "BINAX LEGIONELLA URINARY ANTIGEN EIA". The FDA issued a decision of Substantially Equivalent on September 20, 1994. The device falls under product code MJH (Legionella, Spp., Elisa), a Class II device regulated under 21 CFR 866.3300. Binax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1994
Date Received
October 15, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Legionella, Spp., Elisa
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

Other clearances by Binax, Inc.

  • K090301 — BINAXNOW PBP2A TEST, MODEL 890-000 (April 14, 2010)
  • 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 MJH

  • K191184 — ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (March 5, 2020)
  • K163273 — TRU Legionella (February 21, 2017)
  • K113190 — TRU LEGIONELLA (February 24, 2012)
  • K061496 — SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST (June 28, 2007)
  • K070522 — MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 (March 15, 2007)
  • K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM (November 26, 2003)
  • K991074 — BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST (December 21, 1999)
  • K982238 — BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELL (August 21, 1998)
  • K911356 — LEGIONELLA STAT IGG/IGM TEST KIT (July 30, 1992)

FDA data resources