IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
FDA 510(k) clearance K032850 · decided 2004-03-18
Clearance details
- K-number
- K032850
- Device name
- IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
- Applicant
- Immco Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-12
- Decision date
- 2004-03-18
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- NBT
- Device class
- 2
- Regulation number
- 866.5785
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Buffalo, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ASCA-CHEK (K071711) | Techlab Inc., Corporate Research Center | 2007-11-07 |
| TECHLAB ASCA-CHEK (K051927) | Techlab, Inc. | 2006-04-06 |
| AESKULISA ASCA A (K051492) | Aesku, Inc. | 2005-11-14 |
| BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT (K042579) | The Binding Site | 2005-07-28 |
| IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) (K032860) | Immco Diagnostics, Inc. | 2004-03-18 |
| QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA (K000733) | Inova Diagnostics, Inc. | 2001-05-21 |
| QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA (DEN000007) | Inova Diagnostics, Inc. | 2000-08-16 |
Recalls involving this device
No recalls on record reference this clearance.