The following data is part of a premarket notification filed by Ab Sangtec Medical with the FDA for Transtat-cmv(tm).
| Device ID | K903308 |
| 510k Number | K903308 |
| Device Name: | TRANSTAT-CMV(TM) |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | AB SANGTEC MEDICAL 3603-D HAVEN AVE. Menlo Park, CA 94025 |
| Contact | Philippe Pouletty |
| Correspondent | Philippe Pouletty AB SANGTEC MEDICAL 3603-D HAVEN AVE. Menlo Park, CA 94025 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-24 |
| Decision Date | 1990-12-04 |