Panels › Immunology › Product code NBT · Class 2
Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Regulation 866.5785
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NBT
| Company | 510(k)s | Recalls |
|---|---|---|
| Immco Diagnostics, Inc. | 2 | 0 |
| Inova Diagnostics, Inc. | 2 | 0 |
| Aesku, Inc. | 1 | 0 |
| The Binding Site | 1 | 0 |
| Techlab, Inc. | 1 | 0 |
| Techlab Inc., Corporate Research Center | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 7, 2007 | K071711 | ASCA-CHEK Techlab Inc., Corporate Research Center | NBT |
| Apr 6, 2006 | K051927 | TECHLAB ASCA-CHEK Techlab, Inc. | NBT |
| Nov 14, 2005 | K051492 | AESKULISA ASCA A Aesku, Inc. | NBT |
| Jul 28, 2005 | K042579 | BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT The Binding Site | NBT |
| Mar 18, 2004 | K032860 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) Immco Diagnostics, Inc. | NBT |
| Mar 18, 2004 | K032850 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) Immco Diagnostics, Inc. | NBT |
| May 21, 2001 | K000733 | QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA Inova Diagnostics, Inc. | NBT |
| Aug 16, 2000 | DEN000007 | QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA Inova Diagnostics, Inc. | NBT |
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