The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Influenza A & B Test.
| Device ID | K080380 |
| 510k Number | K080380 |
| Device Name: | SAS INFLUENZA A & B TEST |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Robbi Perry |
| Correspondent | Robbi Perry SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-13 |
| Decision Date | 2009-07-23 |
| Summary: | summary |