The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Meningitis/encephalitis (me) Panel For Use With Filmarray Torch.
Device ID | K160462 |
510k Number | K160462 |
Device Name: | FilmArray Meningitis/Encephalitis (ME) Panel For Use With FilmArray Torch |
Classification | Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System |
Applicant | BIOFIRE DIAGNOSTICS, LLC 390 WAKARA WAY Salt Lake City, UT 84108 |
Contact | Kristen J. Kanack |
Correspondent | Kristen J. Kanack BIOFIRE DIAGNOSTICS, LLC 390 WAKARA WAY Salt Lake City, UT 84108 |
Product Code | PLO |
CFR Regulation Number | 866.3970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-19 |
Decision Date | 2016-03-17 |
Summary: | summary |