510(k) K072547
K072547 is an FDA 510(k) premarket notification submitted by Idaho Technology, Inc. for the device "JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124". The FDA issued a decision of Substantially Equivalent on December 19, 2007. The device falls under product code OEH (Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit), a Class II device regulated under 21 CFR 866.3280. Idaho Technology, Inc. has at least 7 other 510(k) clearances on record.
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.