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510(k) K072547

JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 by Idaho Technology, Inc. — Product Code OEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2007
Date Received
September 10, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
Device Class
Class II
Regulation Number
866.3280
Review Panel
MI
Submission Type

To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis.

Other clearances by Idaho Technology, Inc.

  • K120267 — FILMARRAY RP PANEL (May 15, 2012)
  • K103207 — JBAIDS Q FEVER DETECTION KIT (May 20, 2011)
  • K110764 — FILMARRAY RP PANEL (April 27, 2011)
  • K103175 — FILMARRAY RESPIRATORY PANEL (RP) (February 17, 2011)
  • K072631 — JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 (December 20, 2007)
  • K071188 — MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM (May 21, 2007)
  • K051713 — JBAIDS ANTHRAC DETECTION SYSTEM (November 18, 2005)

Other clearances for product code OEH

  • K131936 — JBAIDS TULAREMIA DETECTION KIT (July 31, 2013)