510(k) K221658
- Device
- Non-variola Orthopoxvirus Real-time PCR Primer And Probe Set
- Applicant
- Centers For Disease Control And Prevention
- 510(k) number
- K221658
- Product code
- NHT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-10
- Date received
- 2022-06-08
- Regulation
- 866.3045
- Classification name
- Assay, Nucleic Acid Amplification, Bacillus Anthracis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Julie Villanueva, PhD
- Address
- 1600 Clifton Rd. NE Ms: H24-11 Atlanta GA US 30329 30329
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 |
| K131930 | JBAIDS ANTHRAX DETECTION KIT | Biofire Diagnostics, Inc. | 2013-08-05 |
| 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#
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FDA Review#
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