Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga)
FDA 510(k) K032860 · Immco Diagnostics, Inc.
510(k) numberK032860
Submission
- Device name
- Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga)
- Applicant
- Immco Diagnostics, Inc.
Buffalo, NY, US - Received
- September 12, 2003
- Decision date
- March 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NBT – Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5785
- Specialty
- Immunology
Other 510(k)s with product code NBT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071711 | Asca-ChekNBT · Traditional | Techlab Inc., Corporate Research Center | 11/07/2007SE |
| K051927 | Techlab Asca-ChekNBT · Traditional | Techlab, Inc. | 04/06/2006SE |
| K051492 | Aeskulisa Asca aNBT · Traditional | Aesku, Inc. | 11/14/2005SE |
| K042579 | Bindazyme Human Asca Igg and Iga Eia Diagnostic Test KitNBT · Traditional | The Binding Site | 07/28/2005SE |
| K032850 | Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg)NBT · Traditional | Immco Diagnostics, Inc. | 03/18/2004SE |
| K000733 | Quanta Lite Asca (S. Cerevisiae) Iga ElisaNBT · Traditional | Inova Diagnostics, Inc. | 05/21/2001SE |
More from Inova Diagnostics, Inc.
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| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAMST · Traditional | 07/28/2017SE |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | 06/19/2017SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | 03/11/2016SE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional | 09/23/2015SE |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | 03/31/2015SE |
| K123713 | Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional | 10/25/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | 10/25/2012SE |
Questions and answers
When was Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga) cleared by the FDA?
Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga) (K032860) received a 510(k) decision of Substantially Equivalent on March 18, 2004, 188 days after the submission was received.
What is the product code of K032860?
The FDA product code is NBT – Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae), a Class II (moderate risk) device regulated under 21 CFR 866.5785.