The following data is part of a premarket notification filed by Aesku, Inc with the FDA for Aeskulisa Cardiolipin Agm.
| Device ID | K040463 |
| 510k Number | K040463 |
| Device Name: | AESKULISA CARDIOLIPIN AGM |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | AESKU, INC 8880 NORTHWEST 18TH TERRACE Miami, FL 33172 |
| Contact | Stanley Ammons |
| Correspondent | Stanley Ammons AESKU, INC 8880 NORTHWEST 18TH TERRACE Miami, FL 33172 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-23 |
| Decision Date | 2004-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250289503068 | K040463 | 000 |
| 04250289503051 | K040463 | 000 |
| 04250289503044 | K040463 | 000 |
| 04250289500845 | K040463 | 000 |
| 04250289500838 | K040463 | 000 |
| 04250289500821 | K040463 | 000 |
| B24235CAAHUE010 | K040463 | 000 |