The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Rsv Test.
| Device ID | K022845 |
| 510k Number | K022845 |
| Device Name: | SAS RSV TEST |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Ricardo R Martinez |
| Correspondent | Ricardo R Martinez SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-27 |
| Decision Date | 2003-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066001974 | K022845 | 000 |