The following data is part of a premarket notification filed by Elias Usa, Inc. with the FDA for Synelisa Cardiolipin Antibodies.
| Device ID | K935288 |
| 510k Number | K935288 |
| Device Name: | SYNELISA CARDIOLIPIN ANTIBODIES |
| Classification | System, Test, Anticardiolipin Immunological |
| 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 | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-03 |
| Decision Date | 1994-01-24 |