VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
FDA 510(k) clearance K990618 · decided 1999-07-23
Clearance details
- K-number
- K990618
- Device name
- VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
- Applicant
- Ventana Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-25
- Decision date
- 1999-07-23
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- MXZ
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection k recall (Z-2716-2011) | Ventana Medical Systems Inc | 2011-07-01 |
| iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended recall (Z-2717-2011) | Ventana Medical Systems Inc | 2011-07-01 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| VENTANA ALK (D5F3) CDX ASSAY (P140025/S025) | Ventana Medical Systems, Inc. | 2025-06-20 |
| VENTANA PD-L1 (SP263) ASSAY (P160046/S020) | Ventana Medical Systems, Inc. | 2025-06-20 |