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510(k) K090964

BINAXNOX STAPHYLOCOCCUS AUREUS TEST by Binax, Inc. — Product Code JWX

K090964 is an FDA 510(k) premarket notification submitted by Binax, Inc. for the device "BINAXNOX STAPHYLOCOCCUS AUREUS TEST". The FDA issued a decision of Substantially Equivalent on December 16, 2009. The device falls under product code JWX (Kit, Screening, Staphylococcus Aureus), a Class I device regulated under 21 CFR 866.2660. Binax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2009
Date Received
April 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Staphylococcus Aureus
Device Class
Class I
Regulation Number
866.2660
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)
  • 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)
  • K032166 — BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PA (October 21, 2003)

Other clearances for product code JWX

  • K972030 — STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS (September 8, 1997)
  • K964315 — REMEL STAPH LATEX KIT (February 7, 1997)
  • K945538 — STAPHAUREX PLUS(TM) (June 1, 1995)
  • K926173 — STAPH-A-LEX(TM) SYSTEM (August 10, 1993)
  • K923212 — SLIDEX STAPH-KIT (September 28, 1992)
  • K905617 — VISI-STAPH (March 29, 1991)
  • K902259 — AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT (June 18, 1990)
  • K874019 — STAPHSLIDE (October 28, 1987)
  • K854278 — NEG COMBO BREAKPOINT PANEL POS COMBO (March 4, 1986)
  • K855220 — V-TREND KIT STAPH LATEX TEST (March 3, 1986)

FDA data resources