The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray 2.0 System.
Device ID | K143178 |
510k Number | K143178 |
Device Name: | FilmArray 2.0 System |
Classification | Instrumentation For Clinical Multiplex Test Systems |
Applicant | BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City, UT 84108 |
Contact | Kristen Kanack, Phd |
Correspondent | Kristen Kanack, Phd BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City, UT 84108 |
Product Code | NSU |
CFR Regulation Number | 862.2570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-04 |
Decision Date | 2015-01-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00815381020048 | K143178 | 000 |
00815381020031 | K143178 | 000 |
00851458005143 | K143178 | 000 |
00851458005129 | K143178 | 000 |
00851458005051 | K143178 | 000 |
00815381029058 | K143178 | 000 |
00851458005297 | K143178 | 000 |