The following data is part of a premarket notification filed by Elias Usa, Inc. with the FDA for Elias Cardiolipin Antibodies.
| Device ID | K940403 |
| 510k Number | K940403 |
| Device Name: | ELIAS CARDIOLIPIN ANTIBODIES |
| Classification | System, Test, Anticardiolipin Immunological |
| 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 | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-27 |
| Decision Date | 1994-09-20 |