510(k) K131936
- Device
- JBAIDS TULAREMIA DETECTION KIT
- Applicant
- BIOFIRE DIAGNOSTICS, INC.
- 510(k) number
- K131936
- Product code
- OEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-07-31
- Date received
- 2013-06-27
- Regulation
- 866.3280
- Classification name
- Joint Biological Agent Identification And Diagnostic System (jbaids) Tularemia Detection Kit
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CYNTHIA PHILIPS
- Address
- 390 Wakara Way Salt Lake City UT US 84108 84108
Source Documents#
Other 510(k) Records For Product Code OEH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072547 | JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 | Idaho Technology, Inc. | 2007-12-19 |
Legacy Summary#
summary
FDA Review#
Decision Summary