The following data is part of a premarket notification filed by Aesku.diagnostics with the FDA for Aeskulisa Ena 6 S.
| Device ID | K041753 |
| 510k Number | K041753 |
| Device Name: | AESKULISA ENA 6 S |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | AESKU.DIAGNOSTICS 8880 NW 18TH TERRACE Miami, FL 33172 |
| Contact | Stanley Ammons |
| Correspondent | Stanley Ammons AESKU.DIAGNOSTICS 8880 NW 18TH TERRACE Miami, FL 33172 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-29 |
| Decision Date | 2004-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250289502924 | K041753 | 000 |
| 04250289500449 | K041753 | 000 |