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510(k) K083744

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

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

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Other clearances for product code MJZ

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