JBAIDS Q FEVER DETECTION KIT
FDA 510(k) clearance K103207 · decided 2011-05-20
Clearance details
- K-number
- K103207
- Device name
- JBAIDS Q FEVER DETECTION KIT
- Applicant
- Idaho Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-01
- Decision date
- 2011-05-20
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- OVF
- Device class
- 1
- Regulation number
- 866.3500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.