The following data is part of a premarket notification filed by Elias Usa, Inc. with the FDA for Varelisa Centromere Antibodies.
| Device ID | K944171 |
| 510k Number | K944171 |
| Device Name: | VARELISA CENTROMERE ANTIBODIES |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottsfried Kellermann |
| Correspondent | Gottsfried Kellermann 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 | 1994-08-26 |
| Decision Date | 1994-12-22 |