The following data is part of a premarket notification filed by Biofire Diagnostics, Inc. with the FDA for Jbaids Tularemia Detection Kit.
| Device ID | K131936 |
| 510k Number | K131936 |
| Device Name: | JBAIDS TULAREMIA DETECTION KIT |
| Classification | Joint Biological Agent Identification And Diagnostic System (jbaids) Tularemia Detection Kit |
| Applicant | BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 |
| Contact | Cynthia Philips |
| Correspondent | Cynthia Philips BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 |
| Product Code | OEH |
| CFR Regulation Number | 866.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2013-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851458005020 | K131936 | 000 |