PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
FDA 510(k) clearance K023857 · decided 2003-05-16
Clearance details
- K-number
- K023857
- Device name
- PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 2002-11-20
- Decision date
- 2003-05-16
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- NOM
- Device class
- 1
- Regulation number
- 866.3040
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Redmond, WA, 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 |
|---|---|---|
| MycoMEIA Aspergillus Assay (K243496) | Pearl Diagnostics, Inc. | 2025-08-01 |
| PLATELIA ASPERGILLUS EIA MODEL 62793 (K093678) | Bio-Rad | 2011-01-13 |
| PLATELIA ASPERGILLUS EIA, MODEL 62793 (K060641) | Bio-Rad | 2006-06-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Platelia Aspergillus EIA recall (Z-0348-04) | Bio Rad Laboratories, Inc. | 2004-01-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002) | Bio-Rad | 1996-03-01 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001) | Bio-Rad | 1991-03-14 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032) | Bio-Rad | 1989-07-24 |