K083746 is an FDA 510(k) clearance for the BIOSIGN FLU A+B. This device is classified as a Devices Detecting Influenza A, B, And C Virus Antigens (Class II - Special Controls, product code PSZ).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on November 10, 2010, 693 days after receiving the submission on December 17, 2008.
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 | K083746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2008 |
| Decision Date | November 10, 2010 |
| Days to Decision | 693 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. |