The following data is part of a premarket notification filed by Biofire Diagnostics, Inc. with the FDA for Jbaids Anthrax Detection Kit.
Device ID | K131930 |
510k Number | K131930 |
Device Name: | JBAIDS ANTHRAX DETECTION KIT |
Classification | Assay, Nucleic Acid Amplification, Bacillus Anthracis |
Applicant | BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 |
Contact | Cynthia Phillips |
Correspondent | Cynthia Phillips BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 |
Product Code | NHT |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-27 |
Decision Date | 2013-08-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851458005037 | K131930 | 000 |