B. anthracis Real-time PCR Assay
FDA 510(k) clearance K192871 · decided 2019-11-07
Clearance details
- K-number
- K192871
- Device name
- B. anthracis Real-time PCR Assay
- Applicant
- Centers for Disease Control and Prevention
- Decision
- Substantially Equivalent
- Date received
- 2019-10-08
- Decision date
- 2019-11-07
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- NHT
- Device class
- 2
- Regulation number
- 866.3045
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Centers for Disease Control and Prevention
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| JBAIDS ANTHRAC DETECTION SYSTEM (K051713) | Idaho Technology, Inc. | 2005-11-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AFP MID-PREGNANCY REFERENCE PREPARATION (P820077) | Centers for Disease Control and Prevention | 1984-11-30 |