FDA Product Code
FDA Product Code NBT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5785
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071711 | ASCA-CHEK | Techlab Inc., Corporate Research Center | 2007-11-07 | Traditional | PDF ↗ |
| K051927 | TECHLAB ASCA-CHEK | Techlab, Inc. | 2006-04-06 | Traditional | PDF ↗ |
| K051492 | AESKULISA ASCA A | Aesku, Inc. | 2005-11-14 | Traditional | PDF ↗ |
| K042579 | BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT | The Binding Site | 2005-07-28 | Traditional | PDF ↗ |
| K032860 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) | Immco Diagnostics, Inc. | 2004-03-18 | Traditional | PDF ↗ |
| K032850 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) | Immco Diagnostics, Inc. | 2004-03-18 | Traditional | PDF ↗ |
| K000733 | QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA | Inova Diagnostics, Inc. | 2001-05-21 | Traditional | PDF ↗ |
| DEN000007 | QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA | Inova Diagnostics, Inc. | 2000-08-16 | Post-NSE | — |
Product code NBT · Class II · Immunology. Data: openFDA.