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 |