PAP ANTIBODY KIT
FDA 510(k) clearance K924629 · decided 1993-02-04
Clearance details
- K-number
- K924629
- Device name
- PAP ANTIBODY KIT
- Applicant
- Ventana Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-14
- Decision date
- 1993-02-04
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- DFD
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tucson, AZ, 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 |
|---|---|---|
| VENTANA CEA PRIMARY ANTIBODY (K940242) | Ventana Medical Systems, Inc. | 1996-12-23 |
| PSA ANTIBODY KIT (K924578) | Ventana Medical Systems, Inc. | 1993-02-05 |
Recalls involving this device
No recalls on record reference this clearance.
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 |