The following data is part of a premarket notification filed by Elias Usa, Inc. with the FDA for Elias Ana-hep-2.
| Device ID | K964385 |
| 510k Number | K964385 |
| Device Name: | ELIAS ANA-HEP-2 |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottfried Kellermann, Ph.d. |
| Correspondent | Gottfried Kellermann, Ph.d. ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-04 |
| Decision Date | 1997-03-06 |