The following data is part of a premarket notification filed by Sa Scientific Ltd. with the FDA for Sas Flualert A & B, Sas Influenza A Test.
| Device ID | K132352 |
| 510k Number | K132352 |
| Device Name: | SAS FLUALERT A & B, SAS INFLUENZA A TEST |
| Classification | Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Applicant | SA SCIENTIFIC LTD. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Nelson Torres |
| Correspondent | Nelson Torres SA SCIENTIFIC LTD. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Product Code | GNX |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-29 |
| Decision Date | 2013-08-22 |
| Summary: | summary |