510(k) K103207
- Device
- JBAIDS Q FEVER DETECTION KIT
- Applicant
- IDAHO TECHNOLOGY, INC.
- 510(k) number
- K103207
- Product code
- OVF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-05-20
- Date received
- 2010-11-01
- Regulation
- 866.3500
- Classification name
- Assay, Direct, Nucleic Acid Amplification, Q Fever
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BETH LINGENFELTER
- Address
- 390 Wakara Way Salt Lake City UT US 84108 84108
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary