VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
FDA 510(k) clearance K101234 · decided 2011-08-25
Clearance details
- K-number
- K101234
- Device name
- VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
- Applicant
- Ventana Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-03
- Decision date
- 2011-08-25
- Days to decision
- 479 days
- Clearance type
- Traditional
- Product code
- OWF
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-101 recall (Z-3010-2018) | Ventana Medical Systems Inc | 2018-09-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S058) | Ventana Medical Systems, Inc. | 2026-05-15 |
| HER2 Dual ISH DNA Probe Cocktail (P190031/S015) | Ventana Medical Systems, Inc. | 2026-05-15 |
| PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S059) | Ventana Medical Systems, Inc. | 2025-12-15 |
| HER2 Dual ISH DNA Probe Cocktail (P190031/S014) | Ventana Medical Systems, Inc. | 2025-12-15 |
| CINtec PLUS Cytology (P190024/S015) | Ventana Medical Systems, Inc. | 2025-09-04 |
| CINtec PLUS Cytology (P190024/S014) | Ventana Medical Systems, Inc. | 2025-07-31 |
| VENTANA CLDN18 (43-14A) RxDx Assay (P230018/S001) | Ventana Medical Systems, Inc. | 2025-06-20 |
| PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S057) | Ventana Medical Systems, Inc. | 2025-06-20 |