NBT
8 FDA 510(k) clearances · Product code
188 daysmedian time to decision
441 days90th percentile
8clearances measured
FDA profile
- Official device name
- Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5785
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ASCA-CHEK (K071711) | Techlab Inc., Corporate Research Center | 2007-11-07 |
| TECHLAB ASCA-CHEK (K051927) | Techlab, Inc. | 2006-04-06 |
| AESKULISA ASCA A (K051492) | Aesku, Inc. | 2005-11-14 |
| BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT (K042579) | The Binding Site | 2005-07-28 |
| IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) (K032860) | Immco Diagnostics, Inc. | 2004-03-18 |
| IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) (K032850) | Immco Diagnostics, Inc. | 2004-03-18 |
| QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA (K000733) | Inova Diagnostics, Inc. | 2001-05-21 |
| QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA (DEN000007) | Inova Diagnostics, Inc. | 2000-08-16 |
Track NBT automatically
Every clearance here is in the API, with alerts when new ones post.