510(k) K042579
- Device
- BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
- Applicant
- The Binding Site
- 510(k) number
- K042579
- Product code
- NBT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-07-28
- Date received
- 2004-09-22
- 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
- N
Applicant Contact#
- Contact
- JAY H GELLER
- Address
- West Tower, Suite 4000 2425 W. Olympic Blvd. Santa Monica CA US 90404 90404
FDA Registration Numbers#
- 3003825930
- 3012348571
- 3009935129
- 1122855
- 2026994
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 |
| K051927 | TECHLAB ASCA-CHEK | Techlab, Inc. | 2006-04-06 |
| K051492 | AESKULISA ASCA A | Aesku, Inc. | 2005-11-14 |
| 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 |