K051492 is an FDA 510(k) clearance for the AESKULISA ASCA A. This device is classified as a Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (Class II - Special Controls, product code NBT).
Submitted by Aesku, Inc. (Miami, US). The FDA issued a Cleared decision on November 14, 2005, 161 days after receiving the submission on June 6, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5785.
| 510(k) Number | K051492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2005 |
| Decision Date | November 14, 2005 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | NBT — Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5785 |