The following data is part of a premarket notification filed by Elias Usa, Inc. with the FDA for Varelisa Parietal Cell Antibodies.
| Device ID | K951206 |
| 510k Number | K951206 |
| Device Name: | VARELISA PARIETAL CELL ANTIBODIES |
| Classification | Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control |
| Applicant | ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottfried Kellermann |
| Correspondent | Gottfried Kellermann ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | MLE |
| CFR Regulation Number | 866.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-17 |
| Decision Date | 1995-04-17 |