The following data is part of a premarket notification filed by Idaho Technology, Inc. with the FDA for Jbaids Q Fever Detection Kit.
| Device ID | K103207 |
| 510k Number | K103207 |
| Device Name: | JBAIDS Q FEVER DETECTION KIT |
| Classification | Assay, Direct, Nucleic Acid Amplification, Q Fever |
| Applicant | IDAHO TECHNOLOGY, INC. 390 Wakara Way Salt Lake City, UT 84108 |
| Contact | Beth Lingenfelter |
| Correspondent | Beth Lingenfelter IDAHO TECHNOLOGY, INC. 390 Wakara Way Salt Lake City, UT 84108 |
| Product Code | OVF |
| CFR Regulation Number | 866.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2011-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851458005013 | K103207 | 000 |