510(k) K051927
- Device
- TECHLAB ASCA-CHEK
- Applicant
- TECHLAB, INC.
- 510(k) number
- K051927
- Product code
- NBT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-04-06
- Date received
- 2005-07-18
- Regulation
- 866.5785
- Classification name
- Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID M LYERLY
- Address
- 2001 Kraft Dr. Blacksburg VA US 24060 24060
FDA Registration Numbers#
- 2026994
- 3012348571
- 3009935129
- 3003825930
- 1122855
Source Documents#
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 |
| 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 |
| DEN000007 | QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA | Inova Diagnostics, Inc. | 2000-08-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary