The following data is part of a premarket notification filed by Aesku.diagnostics with the FDA for Aeskulisa Ana Hep-2, Ref 30-7115us.
| Device ID | K081104 |
| 510k Number | K081104 |
| Device Name: | AESKULISA ANA HEP-2, REF 30-7115US |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | AESKU.DIAGNOSTICS MIKROFORUM RING 2 Wendelsheim, DE D-55234 |
| Contact | Jim Radford |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-18 |
| Decision Date | 2008-05-02 |