The following data is part of a premarket notification filed by Aesku.diagnostics with the FDA for Modification To Aeskulisa Ds Dna G.
| Device ID | K081251 |
| 510k Number | K081251 |
| Device Name: | MODIFICATION TO AESKULISA DS DNA G |
| Classification | Anti-dna Antibody, Antigen And Control |
| Applicant | AESKU.DIAGNOSTICS MIKROFORUM RING 2 Wendelsheim, DE D-55234 |
| Contact | Sascha Pfeiffer |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LSW |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-05-02 |
| Decision Date | 2008-05-13 |
| Summary: | summary |