The following data is part of a premarket notification filed by Elias Usa, Inc. with the FDA for Aynelisa M2-antibodies.
| Device ID | K930143 |
| 510k Number | K930143 |
| Device Name: | AYNELISA M2-ANTIBODIES |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottfried Kellerman |
| Correspondent | Gottfried Kellerman ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-12 |
| Decision Date | 1993-05-11 |