The following data is part of a premarket notification filed by Biofire Defense, Llc with the FDA for Filmarray Global Fever Panel External Control Kit.
| Device ID | K202382 |
| 510k Number | K202382 |
| Device Name: | FilmArray Global Fever Panel External Control Kit |
| Classification | Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Applicant | BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City, UT 84107 |
| Contact | Cynthia Phillips |
| Correspondent | Cynthia Phillips BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City, UT 84107 |
| Product Code | PMN |
| CFR Regulation Number | 866.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-20 |
| Decision Date | 2020-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851458005259 | K202382 | 000 |