510(k) DEN000007
- Device
- QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
- Applicant
- Inova Diagnostics, Inc.
- 510(k) number
- DEN000007
- Product code
- NBT
- Decision
- Unknown (DENG)
- Decision date
- 2000-08-16
- Date received
- 2000-07-18
- Regulation
- 866.5785
- Classification name
- Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- BRYS C MYERS
- Address
- 10180 Scripps Ranch Blvd. San Diego CA US 92131 92131
FDA Registration Numbers#
- 2026994
- 3012348571
- 1122855
- 3003825930
- 3009935129
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NBT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071711 | ASCA-CHEK | Techlab Inc., Corporate Research Center | 2007-11-07 |
| K051927 | TECHLAB ASCA-CHEK | Techlab, Inc. | 2006-04-06 |
| K051492 | AESKULISA ASCA A | Aesku, Inc. | 2005-11-14 |
| K042579 | BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT | The Binding Site | 2005-07-28 |
| K032850 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) | Immco Diagnostics, Inc. | 2004-03-18 |
| K032860 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) | Immco Diagnostics, Inc. | 2004-03-18 |
| K000733 | QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA | Inova Diagnostics, Inc. | 2001-05-21 |