510(k) K192871
K192871 is an FDA 510(k) premarket notification submitted by Centers for Disease Control and Prevention for the device "B. anthracis Real-time PCR Assay". The FDA issued a decision of Substantially Equivalent on November 7, 2019. The device falls under product code NHT (Assay, Nucleic Acid Amplification, Bacillus Anthracis), a Class II device regulated under 21 CFR 866.3045. Centers for Disease Control and Prevention has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2019
- Date Received
- October 8, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Nucleic Acid Amplification, Bacillus Anthracis
- Device Class
- Class II
- Regulation Number
- 866.3045
- Review Panel
- MI
- Submission Type
An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.