The following data is part of a premarket notification filed by Biofire Diagnostics, Inc. with the FDA for Filmarray Blood Culture Identification (bcid) Panel.
| Device ID | K130914 |
| 510k Number | K130914 |
| Device Name: | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL |
| Classification | Gram-negative Bacteria And Associated Resistance Markers |
| Applicant | BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 |
| Contact | Beth Lingenfelter |
| Correspondent | Beth Lingenfelter BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 |
| Product Code | PEN |
| Subsequent Product Code | OOI |
| 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 | 2013-04-02 |
| Decision Date | 2013-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020093 | K130914 | 000 |
| 00815381020086 | K130914 | 000 |