JBAIDS TULAREMIA DETECTION KIT
FDA 510(k) clearance K131936 · decided 2013-07-31
Clearance details
- K-number
- K131936
- Device name
- JBAIDS TULAREMIA DETECTION KIT
- Applicant
- Biofire Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-27
- Decision date
- 2013-07-31
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- OEH
- Device class
- 2
- Regulation number
- 866.3280
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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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 |
|---|---|---|
| JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 (K072547) | Idaho Technology, Inc. | 2007-12-19 |
Recalls involving this device
No recalls on record reference this clearance.