The following data is part of a premarket notification filed by Aesku, Inc with the FDA for Aeskulisa Ana 8pro.
| Device ID | K032469 |
| 510k Number | K032469 |
| Device Name: | AESKULISA ANA 8PRO |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| 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 | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-11 |
| Decision Date | 2003-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250289503013 | K032469 | 000 |
| B24235E6PHUE010 | K032469 | 000 |
| 04250289500425 | K032469 | 000 |
| 04250289500456 | K032469 | 000 |
| 04250289500463 | K032469 | 000 |
| 04250289500487 | K032469 | 000 |
| 04250289500524 | K032469 | 000 |
| 04250289500531 | K032469 | 000 |
| 04250289500555 | K032469 | 000 |
| 04250289502917 | K032469 | 000 |
| 04250289502931 | K032469 | 000 |
| 04250289502948 | K032469 | 000 |
| 04250289502962 | K032469 | 000 |
| 04250289502986 | K032469 | 000 |
| 04250289502993 | K032469 | 000 |
| B24235ANAHUE010 | K032469 | 000 |