510(k) K131930
- Device
- JBAIDS ANTHRAX DETECTION KIT
- Applicant
- BIOFIRE DIAGNOSTICS, INC.
- 510(k) number
- K131930
- Product code
- NHT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-08-05
- Date received
- 2013-06-27
- Regulation
- 510(k) Premarket Notification
- Classification name
- Assay, Nucleic Acid Amplification, Bacillus Anthracis
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CYNTHIA PHILLIPS
- Address
- 390 Wakara Way Salt Lake City UT US 84108 84108
FDA Registration Numbers#
- 1050190
Source Documents#
Other 510(k) Records For Product Code NHT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192871 | B. anthracis Real-time PCR Assay | Centers for Disease Control and Prevention | 2019-11-07 |
| K140426 | ANTHRACIS REAL-TIME PCR ASSAY | Centers For Disease Control and Prevention (CDC) | 2014-05-22 |
| K072631 | JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 | Idaho Technology, Inc. | 2007-12-20 |
| K071188 | MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM | Idaho Technology, Inc. | 2007-05-21 |
| K051713 | JBAIDS ANTHRAC DETECTION SYSTEM | Idaho Technology, Inc. | 2005-11-18 |
Legacy Summary#
summary
FDA Review#
Decision Summary