Quanta Lite Asca (S. Cerevisiae) Iga Elisa
FDA 510(k) K000733 · Inova Diagnostics, Inc.
510(k) numberK000733
Submission
- Device name
- Quanta Lite Asca (S. Cerevisiae) Iga Elisa
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- March 6, 2000
- Decision date
- May 21, 2001
- 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 |
| K032860 | Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga)NBT · Traditional | Immco Diagnostics, Inc. | 03/18/2004SE |
| K032850 | Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg)NBT · Traditional | Immco Diagnostics, Inc. | 03/18/2004SE |
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Questions and answers
When was Quanta Lite Asca (S. Cerevisiae) Iga Elisa cleared by the FDA?
Quanta Lite Asca (S. Cerevisiae) Iga Elisa (K000733) received a 510(k) decision of Substantially Equivalent on May 21, 2001, 441 days after the submission was received.
What is the product code of K000733?
The FDA product code is NBT – Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae), a Class II (moderate risk) device regulated under 21 CFR 866.5785.