The following data is part of a premarket notification filed by Aesku.inc with the FDA for Aeskulisa Asca A.
| Device ID | K051492 |
| 510k Number | K051492 |
| Device Name: | AESKULISA ASCA A |
| Classification | Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
| 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 | NBT |
| CFR Regulation Number | 866.5785 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-06 |
| Decision Date | 2005-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817018541 | K051492 | 000 |
| 00847817018534 | K051492 | 000 |
| 04250289503150 | K051492 | 000 |
| 04250289503143 | K051492 | 000 |
| 04250289502900 | K051492 | 000 |
| 04250289502894 | K051492 | 000 |
| 04250289501538 | K051492 | 000 |
| 04250289501521 | K051492 | 000 |