The following data is part of a premarket notification filed by Sa Scientific, Inc. with the FDA for Sas Rota Test.
| Device ID | K990842 |
| 510k Number | K990842 |
| Device Name: | SAS ROTA TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | J. Wessling |
| Correspondent | J. Wessling SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-15 |
| Decision Date | 1999-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066001899 | K990842 | 000 |