K223016 is an FDA 510(k) clearance for the BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit. This device is classified as a Devices Detecting Influenza A, B, And C Virus Antigens (Class II - Special Controls, product code PSZ).
Submitted by Bd (Sparks, US). The FDA issued a Cleared decision on January 27, 2023, 120 days after receiving the submission on September 29, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3328. An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection..
| 510(k) Number | K223016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2022 |
| Decision Date | January 27, 2023 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PSZ - Devices Detecting Influenza A, B, And C Virus Antigens |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3328 |
| Definition | An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection. |