The following data is part of a premarket notification filed by Biofire Defense, Llc with the FDA for Biofire Covid-19 Test 2.
Device ID | K211079 |
510k Number | K211079 |
Device Name: | BioFire COVID-19 Test 2 |
Classification | Respiratory Specimen Nucleic Acid Sars-cov-2 Test |
Applicant | BioFire Defense, LLC 79 W 4500 S, Suite 14 Salt Lake City, UT 84107 |
Contact | Cynthia Phillips |
Product Code | QQX |
CFR Regulation Number | 866.3981 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-12 |
Decision Date | 2021-11-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851458005235 | K211079 | 000 |
00851458005228 | K211079 | 000 |