The following data is part of a premarket notification filed by Biofire Diagnostics, Inc. with the FDA for Jbaids Plague Detection Kit.
Device ID | K131729 |
510k Number | K131729 |
Device Name: | JBAIDS PLAGUE DETECTION KIT |
Classification | Yersinia Spp. Reagents |
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 | OIH |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-12 |
Decision Date | 2013-07-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851458005044 | K131729 | 000 |