The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Biofire Blood Culture Identification 2 (bcid2) Panel.
| Device ID | K193519 |
| 510k Number | K193519 |
| Device Name: | BioFire Blood Culture Identification 2 (BCID2) Panel |
| Classification | Gram-negative Bacteria And Associated Resistance Markers |
| Applicant | BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Contact | Kristen Kanack |
| Correspondent | Kristen Kanack BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Product Code | PEN |
| Subsequent Product Code | PAM |
| Subsequent Product Code | PEO |
| CFR Regulation Number | 866.3365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-19 |
| Decision Date | 2020-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020338 | K193519 | 000 |