JBAIDS ANTHRAC DETECTION SYSTEM
FDA 510(k) clearance K051713 · decided 2005-11-18
Clearance details
- K-number
- K051713
- Device name
- JBAIDS ANTHRAC DETECTION SYSTEM
- Applicant
- Idaho Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-27
- Decision date
- 2005-11-18
- Days to decision
- 144 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
- Yes
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| B. anthracis Real-time PCR Assay (K192871) | Centers for Disease Control and Prevention | 2019-11-07 |
| ANTHRACIS REAL-TIME PCR ASSAY (K140426) | Centers For Disease Control and Prevention (CDC) | 2014-05-22 |
| JBAIDS ANTHRAX DETECTION KIT (K131930) | Biofire Diagnostics, Inc. | 2013-08-05 |
| JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 (K072631) | Idaho Technology, Inc. | 2007-12-20 |
| MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM (K071188) | Idaho Technology, Inc. | 2007-05-21 |
Recalls involving this device
No recalls on record reference this clearance.