JBAIDS ANTHRAX DETECTION KIT
FDA 510(k) clearance K131930 · decided 2013-08-05
Clearance details
- K-number
- K131930
- Device name
- JBAIDS ANTHRAX DETECTION KIT
- Applicant
- Biofire Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-27
- Decision date
- 2013-08-05
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- NHT
- Device class
- 2
- Regulation number
- 866.3045
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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| B. anthracis Real-time PCR Assay (K192871) | Centers for Disease Control and Prevention | 2019-11-07 |
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| JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 (K072631) | Idaho Technology, Inc. | 2007-12-20 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable th recall (Z-2644-2014) | Biofire Defense | 2014-09-15 |