The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Eti-ea-g Assay.
| Device ID | K992191 |
| 510k Number | K992191 |
| Device Name: | ETI-EA-G ASSAY |
| Classification | Epstein-barr Virus, Other |
| Applicant | DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
| Contact | Judith J Smith |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-06-28 |
| Decision Date | 1999-07-12 |
| Summary: | summary |