NBT — Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) Class II
FDA product code NBT covers "Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)", a Class II medical device regulated under 21 CFR 866.5785. Submissions are reviewed by the Immunology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NBT
- Device Class
- Class II
- Regulation Number
- 866.5785
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K071711 | techlab inc., corporate research center | ASCA-CHEK | November 7, 2007 |
| K051927 | techlab | TECHLAB ASCA-CHEK | April 6, 2006 |
| K051492 | aesku | AESKULISA ASCA A | November 14, 2005 |
| K042579 | binding site | BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT | July 28, 2005 |
| K032850 | immco diagnostics | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) | March 18, 2004 |
| K032860 | immco diagnostics | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) | March 18, 2004 |
| K000733 | inova diagnostics | QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA | May 21, 2001 |
| DEN000007 | inova diagnostics | QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA | August 16, 2000 |