The following data is part of a premarket notification filed by Aesku, Inc with the FDA for Aeskulisa Ana Hep-2.
| Device ID | K040953 |
| 510k Number | K040953 |
| Device Name: | AESKULISA ANA HEP-2 |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| 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 | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-12 |
| Decision Date | 2004-06-23 |