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510(k) K083744

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 by Binax, Inc. — Product Code MJZ

K083744 is an FDA 510(k) premarket notification submitted by Binax, Inc. for the device "BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010". The FDA issued a decision of Substantially Equivalent on September 1, 2009. The device falls under product code MJZ (Kit, Direct Antigen, Positive Control), a Class I device regulated under 21 CFR 862.1660. Binax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2009
Date Received
December 16, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Direct Antigen, Positive Control
Device Class
Class I
Regulation Number
862.1660
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)
  • 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 MJZ

  • K972182 — ABBOTT STREP A CONTROLS (August 13, 1997)
  • K972129 — CHLAMYDIATROL AG (August 12, 1997)

FDA data resources